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The total ankle segment of joint replacement has been on our minds, as industry expects Stryker to divest its STAR ankle prior to its slated acquisition of Wright Medical. We’ll see where the system ends up. Total ankles have also appeared in recent headlines, with the Vilex acquisition of DT MedTech and the Hintermann Total Ankles.
We expect growing competition in the space, as companies seek to perfect designs, utilize different materials and release patient matching instrumentation and other enabling technology in new generations of total ankles.
Here we review four ankle devices that received FDA 510(k) clearance this year. Two represent companies’ entrance into the total ankle replacement market (In2Bones and Paragon 28), one is a line extension (Integra LifeSciences) and one is a company’s first FDA 510(k) clearance (Kinos Medical).
In2Bones | Quantum Total Ankle, K191380
- Submitted May 2019, granted January 2020
- Primary predicate: Tornier Salto Talaris (K090076 and K153452)
- For primary or revision procedures; in the U.S., intended for cemented use only
- Implant was designed with OrthoPlanify Patient Specific Instrumentation (PSI), which allows the surgeon to modify, adjust and manipulate views in a browser
- Initial launch commenced in mid-2020; full launch slated for 1Q21
- Upon additional anticipated FDA clearances, it will be the second total ankle on the market with this patient CT-guided technology, following Wright Medical
- Represents the company’s entrance into ankle joint replacement
- About the company:
- Launched in 2014, headquartered in Memphis, Tennessee
- Focused on upper and lower extremities with hardware and biologics
- Leadership and staff has extensive industry experience at Aesculap Implant Systems, Avanta Orthopedics, Implex, MMI, Newdeal, Nexa Orthopedics, PLUS Orthopedics, Smith+Nephew, Solana Surgical, Stryker, Tornier, Wright Medical
Integra Lifesciences | Cadence Total Ankle, K201507
- Submitted June 2020, granted within the same month
- Primary predicate: Integra (Ascension Orthopedics) Total Ankle Replacement (K151459; Integra acquired Ascension in 2011. Initial U.S. procedures with Cadence occurred in 2016.)
- Indicated for primary and revision procedures; in the U.S., intended for cemented use only while intended for cemented or cementless use ex-U.S.
- The scope of the Cadence system is being extended to include additional options for the talar domes; the new option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design
- New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design
Kinos Medical | Kinos Axiom Total Ankle, K192778
- First FDA 510(k)
- Submitted September 2019, granted June 2020
- Primary predicate: Wright Medical INFINITY Total Ankle (K123954 and K140749)
- Indicated for primary and revision procedures; intended for cemented use only
- Three-component system: tibial implant fixed to the tibia, bearing implant assembled to the tibial implant and talar implant affixed to the talus
- Technology is based on research by Drexel professor Sorin Siegler, which revealed that the ankle joint is not fixed, but moves along a flat plane and also a side-to-side angle; his discovery led him to recalibrate the shape and orientation of the talus
- The goal is to perfectly match hardware to the anatomy of individual patients using software imaging technology
- About the company:
- Formed in 2017 in Wayne, Pennsylvania as a spinout of Drexel University
- Leadership brings experience from Flower Orthopedics, Globus Medical
Paragon 28 | APEX 3D Total Ankle Replacement, K192994 (pictured)
- Submitted October 2019, granted July 2020
- Primary predicates: Wright Medical INVISION Total Ankle Revision (K171067), Tornier Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle (K151459)
- Indicated for primary and revision procedures; intended for cemented use only
- Features porous 3D-printed implants and Vitamin E infused highly cross-linked polyethylene
- Represents the company’s entrance into joint replacement, a complement to its present devices for fracture repair in the foot/ankle
