We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside of the U.S. and these clearances mark their entry into the market. ... Read more »
Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but also obtained for a spine product.... Read more »
The total ankle market is attractive for current and new players. We review four total ankle devices, three from new entrants in the space, that received FDA 510(k) clearance this year.... Read more »
Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list of new products each year. This month, we recap multiple launches from CarboFix Orthopedics, Cutting Edge Spine, Life Spine, Medacta and SeaSpine.... 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's orthopedic panel cleared 49 products in April, we’ve chosen updates from Arthrex, Medacta, OrthAlign, Akros Medical and Subchondral Solutions.... 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 clearance marks the company’s entrance into the total ankle replacement market and complements its products for upper and lower extremities. ... Read more »
One of our favorite lists that we compile every year is newer companies that hit our radar. This review pinpoints 17 companies that received their first FDA 510(k) clearances last year, so you’ll mostly find new names in the segments of Joint Replacement, Spine, Trauma Sports Medicine.... Read more »
This month’s recap highlights devices of interest that received first clearances from companies new on our radar, like Augmedics, Avanti Orthopaedics, NanoOrtho, Nebula Surgical and Sonex Health, and the latest devices from Integra, Think Surgical, ExsoMed and Pantheon Spinal.... 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 »
THINK Surgical's TSolution One® active robot for total knee replacement was previously CE Marked. ... Read more »
Spine implants accounted for the majority of the additive manufactured products that received FDA 510(k) clearance in 2019. Our review of clearances include the industry's top players and two companies with their very first orthopedic-related 510(k)s: Additive Implants and Addivation Medical.... Read more »
This month, we look at companies that received their first orthopedic-related clearance such as FX Shoulder USA, Amplify Surgical and restor3d, and others like Exactech, Smith+Nephew and THINK Surgical that have interesting new technologies or line expansions.... Read more »
The first of its kind biomaterial is offered as an alternative to PEEK and titanium materials for interbody devices. ... Read more »
How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification and validation work you need to complete prior to submission.... Read more »
Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. This is the first and only 3D-printed lateral expandable device on the market. ... Read more »
Nine shoulder replacement implants, including two stemless offerings, and one positioning guide received FDA 510(k) clearance thus far in 2019. We recap each product's specifications. ... Read more »
The Tether represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years. ... Read more »
Heading into the NASS Annual Meeting, we share product clearances for lesser-known companies to keep on your radar: Integrity Implants, MiRus, Omnia, Silony and more. ... Read more »
Arthrex, CONMED, DePuy Synthes and Zimmer Biomet are among the companies that received FDA 510(k) clearances in June.... 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 external fixator device is designed to shorten surgical time, simplify inventory and enhance patient care, and is used with SixFix deformity analysis and correction software. ... 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 »
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 »
Shoulders and ankles comprise the largest share of the extremities joint reconstruction segment. Arthrex, Catalyst OrthoScience, DJO, Exactech, Stryker and Zimmer Biomet have continued to grow their offerings of these devices in 2019 to keep extremities replacement momentum going. ... 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 »
This month’s recap highlights regulatory announcements made from the AAOS exhibit hall floor. A few products gained clearance earlier this year and the company strategically held its announcement for this month. ... Read more »
The Rotium Bioresorbable Wick supports the regeneration of healthy tendon in the healing of rotator cuff injuries.... Read more »
The Alteon Cup is used with the Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners. A patented gamma irradiation and mechanical annealing process, tailored to the vitamin E content, is used to achieve the desired crosslink density for these liners.... Read more »
In January, Globus Medical and Zimmer Biomet received key robotic FDA 510(k) clearances, while five companies within the spine, sports medicine and trauma markets received their first clearances. ... 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 »
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 »
By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."... 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 »
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 »
Exactech’s FDA-cleared Equinoxe is competition for Wright Medical and Zimmer Biomet’s offerings. The three are the only FDA-cleared stemless shoulders in the U.S.... Read more »
The company debuted its suite of FDA-510(k)-cleared trauma products in four families at the 2018 American Academy of Orthopaedic Surgeons annual meeting.... Read more »
The company is the first to receive 510(k) clearance for an electronic torque indicating device.... Read more »
IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.... 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 »
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 »
Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system.... Read more »
Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip.... Read more »
Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... 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 »
Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »
Thomas “Toney” Russell, M.D., an orthopaedic trauma surgeon and President and CEO of Innovision, developed the N-force fixation platform to meet his own clinical needs in optimal fixation of fractures in the extremities and pelvis. The N-force system was a massive regulatory endeavor for a surge... Read more »
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... 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 »
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. 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 »
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 »
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 »
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 »
