AAOS 2016 Recap: Product Launches and Clearances

• Posted in Business Critical | March 10, 2016 | Comments (0)
• Tags: product launch, additive manufacturing, orthopedic industry, conference, technology, bundled payment, AAOS
• By: Hannah Corcoran

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.