The company seeks to gain clearance for its sports medicine portfolio within 3Q21. ... Read more »
New year, new entrants to the U.S. orthopedic market. This installation of the 510(k) recap offers up companies based in the U.S., China and Switzerland, and spans four of the major industry segments: Joint Replacement, Spine, Trauma and Sports Medicine. ... Read more »
The VELYS Robotic-Assisted Solution adapts to the surgical workflow, and helps surgeons execute accurate bony cuts. ... Read more »
This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six companies we chose to highlight received their clearance within the last quarter of 2020. Geographically, they span the U.S., Australia and Italy. ... Read more »
Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap relevant. Here are 10 clearances that I found to be of interest throughout 2020. ... Read more »
The clearance expands VSP Surgical Planning applications in partnership with Exactech. ... Read more »
This month’s recap rounds up many companies new on our radar, helmed by people who've known the industry for a long time. Geographically, they span the U.S., Canada, France and Turkey. ... Read more »
The zero-step titanium alloy and nitinol locking plate system provides continuous compression and torsional stability. ... Read more »
This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both cementless or cemented fixation. ... Read more »
The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market. ... Read more »
FDA cleared 40 orthopedic products in May. We highlight four companies that may be new names to you as well as their technology. ... Read more »
To date in 2020, joint replacement players like Arthrex, Conformis, DePuy Synthes, Medacta, Zimmer Biomet and others have gained FDA 510(k) clearance for a variety of updates and line extensions for their knee, hip and shoulder devices. ... Read more »
VERASENSE is a sensor-assisted device used with leading knee implant systems during primary and revision total knee procedures. ... Read more »
The device is specifically designed to negate common risks of radial implants, such as limited range of motion, subluxation, distal component failure and osteolysis. ... Read more »
The automated Regulatory Affairs Management Suite FDA 510(k) submission tool minimizes errors to avoid U.S. medical device market entry delays. ... Read more »
The augmented reality system allows surgeons to visualize anatomy in real time, as if using x-ray vision, to guide instruments and implants. The first application addresses spinal procedures. ... Read more »
The number of companies in the trauma space may surprise you since the largest orthopedic players—DePuy Synthes, Stryker, Zimmer Biomet and Smith & Nephew—seem to dominate the news. In anticipation of the OTA Annual Meeting this week, and in response to your requests for continued coverage o... Read more »
The next-generation system was designed to improve simplicity and ease of use for minimally invasive lumbar procedures, and is part of a lumbar fusion solution suite that also includes Orbit discectomy instruments. ... Read more »
This month we focus on products that rebuild knees, hips and extremities. Two are from companies receiving their first orthopedic-related clearance; most are from folks that you know: LimaCorporate, MicroPort Orthopedics, Zimmer Biomet, and so forth. ... Read more »
The company has filed a submission to FDA for clearance to market its active robot for use in total knee replacement procedures. ... Read more »
Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly reduce the risk of delays once a 510(k) is under review.... Read more »
With these 510(k)s in hand, TIGER SHARK C Cervical Interbody and BOOMERANG Anterior Cervical Plate are set to enter the robust spinal implant market. ... Read more »
NanoBone Bone Graft used as a standalone in posterolateral spinal fusion may represent a significant advancement in patient care. Eliminating the need to mix synthetic graft with autograft or to harvest and concentrate bone marrow aspirate can offer savings of time and money, and can ... Read more »
Today, orthopedists rely on external motion and static x-ray to assess joint stability and spinal movement. With DDR, orthopedists and musculoskeletal specialists can acquire a full view of the skeletal system in supine and prone positions to view changes in the bone and articulations throughout the... Read more »
Orthopedic companies large, mid-sized and small are gaining FDA clearance for products in new materials, and made with attractive manufacturing methods like 3D printing. Companies like Kuros Biomedical and Nvision are making strategic decisions to move into adjacent markets. ... Read more »
MiRus received FDA 510(k) clearance for Europa, a pedicle screw made with MoRe®, a proprietary molybdenum rhenium superalloy expected to provide more strength, ductility and durability than titanium and cobalt. ... Read more »
The company now has FDA 510(k) clearance for knee, spine and brain applications on one robotic platform. ROSA SPINE features dynamic tracking that allows it to move with the patient, supporting accuracy without the need to be attached to the patient or the surgical table. ... Read more »
CurvaFix is developing implantable products to improve bone repair following serious fracture and injury. This is the company’s first product, and first FDA 510(k) clearance. ... Read more »
SIG seeks to provide patient care by reducing complications like pneumonia, time in intensive care units, chronic pain, ventilator support, chest wall deformity, the need for tracheostomy and a significant reduction to the overall cost to the healthcare system.... Read more »
Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more. ... Read more »
This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus on predicate devices that are 10 years old or less, and its framework is aimed at efficiently advancing beneficial technology to patients while keeping with FDA’s standards for safety and e... Read more »
Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »
The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing.... Read more »
We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth.... Read more »
To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.... Read more »
The company is the first to receive 510(k) clearance for an electronic torque indicating device.... Read more »
Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices.... Read more »
This is reportedly the first PEEK-OPTIMA HA vertebral body replacement to receive FDA clearance.... Read more »
The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.... Read more »
MicroPort Orthopedics launched the Procotyl Prime acetabular cup, the next step in the evolution of the Dynasty Acetabular Cup System. The device received FDA 510(k) clearance at the end of 2Q17.
... Read more »
Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.... Read more »
Emerging Implant Technologies acquired a portfolio of 3-D printed expandable spinal fusion cages for vertical and lateral expansion. The first products based on these patents will launch in 2018.... Read more »
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.... Read more »
Revamped marketing and R&D priorities, product launches, recent licensing agreements and now, an acquisition and portfolio expansion with the ExoShape system—all play a part in the company's multi-pronged turnaround initiative. The all-PEEK fasteners fill a gap in the company's offerings.... Read more »
Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »
Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... Read more »
Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »
CoorsTek Medical's CeraSurf®-p ceramic femoral heads have been incorporated into a U.S. orthopaedic device customer's hip system that has received FDA 510(k) clearance.... Read more »
Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions.... Read more »
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
FDA clarified changes to the Custom Device Exemption provision through a final guidance document.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge Medical, Everest Spine, Fairway Medical, Foundry (Newco XI), Frontier Medical, InSurgical, NCS Lab, Ouroboros Medical, Stabiliz Orthopaedics, Z-Medic... Read more »
Medical Modeling received FDA 510(k) clearance to market the VSP® System. Initial applications include orthognathics and reconstruction, applying virtual surgical planning in a variety of maxillofacial procedures. (Source: Medical Modeling, Inc.)... Read more »
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet, Intelligent Implant Systems, Osseon Therapeutics, Providence Medical, Safe Orthopaedics, Shanghai Kinetic, Shoulder Options, Weigao Orthopa... Read more »
Z-Medical received FDA 510(k) clearance to market the Z-Double Thread Compression Screw for use in foot and ankle applications. The products will be distributed by Nextremity Solutions under the Precision Ready™ brand. (Source: Z-Medical GmbH + Co. KG)... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Ceram, an independent materials technology company, recently partnered with Greatbatch Medical, providers of critical technologies used in medical devices, to help Greatbatch gain FDA clearance of its hydroxyapatite coating master file by providing all the necessary testing on the coating for a 510(... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.
Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »
Co-authored by Keith Kennedy
Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »
