AAOS 2016 Recap: Product Launches and Clearances

The theme of change dominated the 2016 AAOS Annual Meeting, with robotics, navigation, additive manufacturing and bundled payments leading conversations. Though not yet fully mainstream, large and small orthopaedic OEMs gave the sense that these topics are gaining traction and represent greater shifts taking place to improve and measure clinical outcomes.

As industry navigates these changes, companies continue to collaborate with each other to stay competitive, evidenced by partnership announcements at AAOS. To name a few, LifeNet Health and Arthrex extended their collaboration on allograft implants and instruments; Amedica and Celling Biosciences announced co-development of spinal fusion devices; DePuy Synthes partnered with Value Stream Partners to manage bundled payments; and EQT, along with Hansjörg Wyss, completed its acquisition of Lima Corporate.

In the event that you missed some of the product launches and clearances announced at AAOS, BONEZONE highlights the following moves made by your peers.

Arthroscopy/Soft Tissue

Orthopaedic manufacturers in the arthroscopy/soft tissue market continue to roll out products that allow for a minimally invasive approach, exemplified by Cayenne’s BioWick™ SureLock™ Implant.

Cayenne Medical

• Commenced U.S. launch of the BioWick SureLock Implant, an interpositional scaffold wick designed to address the biology issue associated with rotator cuff repair failure.
• The BioWick scaffold wick comprises aligned, copolymer microfibers designed to mimic the extracellular matrix of a rotator cuff tendon. SureLock is deployed arthroscopically between tendon and bone, allowing surgeons to maintain their current technique while reducing bone removal through a smaller pilot hole.

Proxy Biomedical

• Developed a high strength resorbable USP 2 suture for fracture and soft tissue repair applications.
• The multifilament PGA suture features an average knot-pull, tensile value of >110N and straight tensile strength of 185N, exceeding the minimum knot-pull textile requirements of 62.3N for a USP 2 classification.

Joint Reconstruction

Zimmer Biomet launched several products to expand its hip and knee portfolio, while others introduced their latest navigation devices and innovations.

Brainlab

• Introduced Auto-Knee, a new feature of TraumaCad 2.5 that supports pre-operative planning of knee arthroplasty by automatically registering anatomical landmarks.
• Auto-Knee is also designed to support knee surgery through planning of AP resection lines, template positioning and size estimation and simulation of knee alignment.
• A feature of the technology is the consideration of soft tissue impact before the surgeon makes an incision, according to Marc Mackey, General Manager of Orthopaedics, Voyant Health at Brainlab.

ConforMIS

• Commenced full commercial launch of the iTotal® PS customized posterior stabilized total knee.
• Over 1,000 patients have been treated with iTotal PS during limited launch over the past 12 months.
• This initiative allows the company three times the opportunity to compete in the knee market, according to Adam Hayden, Senior Vice President of Marketing at ConforMIS.

Exactech

• Unveiled new revision arthroplasty devices, including the Equinoxe® Humeral Reconstruction Prosthesis, Revision Knee System, the Alteon® Monobloc Revision Femoral Stem and the Tapered Wedge Hip Spacer, the latest addition to the InterSpace® line.
• Full U.S. launch of the products is expected over the next six to nine months, with a likely 2017 ex-U.S. launch for hip and knee.

OrthAlign

• Received FDA 510(k) clearance to market UniAlign™, a handheld, single-use navigation device for Unicompartmental Knee Arthroplasty (UKA). Product launch is slated for mid-to late-summer 2016.
• UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. It is open platform, and requires no pre-op imaging or custom cutting guides.

Smith & Nephew

• Launched the REDAPT™ Revision Acetabular Fully Porous Cup with CONCELOC™ Technology, the company’s first 3D-printed titanium hip implant.
• CONCELOC is offered as an alternative to external porous coatings, such as sintered beads or fiber mesh used in other uncemented implants, to support bone ingrowth. It is available on a limited basis in the U.S.

Zimmer Biomet

• Expanded its hip portfolio with launches of the Echo® Bi-Metric® Microplasty® Stem, G7® Dual Mobility Construct and Arcos® One-Piece Revision System.
• Expanded its knee portfolio with the Persona® Medial Congruent™ Bearing and OsseoTi® Tibial Sleeves.
• Received FDA 510(k) clearance for compatibility of the Nexel™ Total Elbow with the Comprehensive® Segmental Revision System (SRS). This marks the 1st submission by ZBH to establish compatibility of two separate ZBH implant systems. The distal component of Biomet’s Comprehensive SRS humeral system, when combined with Zimmer’s Nexel Total Elbow, is designed for elbow joint replacement, while the remaining components support proximal or total humeral reconstruction when used with the glenoid component of the Comprehensive Shoulder.

Orthobiologics

Biologics continue to gain momentum in the industry, illustrated by the following launches.

AlloSource

• Launched ProChondrix® Cartilage Restoration Matrix, a cellular 3D fresh cartilage allograft to support cartilage regeneration, and designed to match biomechanical and biochemical properties of normal hyaline cartilage and restore a smooth articular cartilage surface.

Bioventus

• Launched the CellXtract™ novel cell and bone marrow extraction tool and SIGNAFUSE™, a bioactive bone graft putty recently acquired from BioStructures.

BONESUPPORT

• Launched a 5mL version of CERAMENT™|G antibiotic-eluting bone substitute in the EU. The smaller volume option expands the application of the injectable product in small joint and extremity indications.
• The company expects to initiate a pivotal U.S. clinical trial for the product in 2Q16.

Spine

Spine, the second largest segment in orthopaedics by revenue, saw nearly as many announcements as the market leader, joint reconstruction. Notably, Stryker Spine announced two product launches and a 510(k) clearance.

Cardinal Spine

• PaxMed International, on behalf of Cardinal Spine, received FDA 510(k) clearance of the C-VBR vertebral body replacement—reportedly the second cervical vertebral body replacement device to be cleared by FDA and the first such device designed with no possibility of reduction in height after surgery.

EOS

• Received CE Mark approval for spineEOS, an online 3D planning software based on EOS bi-planar imaging.
• This supports the creation of an optimized treatment plan to achieve improved sagittal alignment in the treatment of Adolescent Idiopathic Scoliosis and adult degenerative/deformative spine conditions.

Stryker

• Received FDA 510(k) clearance for Tritanium® PL, a highly-porous posterior lumbar cage manufactured via additive manufacturing. Launch will occur in 2Q16.
• Launched the Xia 4.5 Cortical Trajectory implants and instruments for LITe® (Less Invasive Technologies) Lumbar Interbody Fusion procedures. The cortical trajectory procedure allows for a smaller midline incision, and is intended to be more muscle-sparing than standard open procedures.
• Launched the Aero®-C Cervical Stability System, reportedly the only ACDF device to offer uniform compression across the interbody space. The Aero platform employs an advanced anchor fixation system designed to draw the vertebral bodies toward the implant, creating compressive forces at the implant-to-endplate interface and providing an environment for fusion.

ulrich

• ulrich medical USA launched uNion®, a titanium alloy cervical plate for stabilization and anterior fixation as an adjunct to fusion in the treatment of degenerative disc disease.
• uNion features a low-profile plate design with streamlined instrumentation, a large graft window and a range of implant sizes for 1- to 4-level treatment requirements.

Xtant Medical

• Received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.
• Aranax comprises a pre-sterilized, ready-to-use implant, while Irix-A consists of an integrated, PEEK-enclosed titanium ring. In the U.S., Aranax received FDA 510(k) clearance in 3Q15 and Irix-A launched in 1Q15.

Trauma

Foot and ankle remains an attractive market, including in trauma, evidenced by Extremity Medical’s product launches.

Extremity Medical

• Commenced U.S. launch of IO FIX 2.0™ implants and instruments for midfoot fusion indications.
• While based on the original IO FIX system, this next-generation line is modular, supporting greater intra-operative versatility. To date, >20,000 of its constructs have been implanted worldwide.

Tyber Medical

• Received FDA 510(k) clearance of BioTy™ Modified Surface Treatment for use on its Headless Screw System.
• The company also expanded its exclusive licensing agreement with Northeastern University to further enhance BioTy proprietary technology and IP.

Send comments on this article to Carolyn LaWell.

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