BETA
Fort Wayne orthopedic implant manufacturer with U.S.-marketed toe and radial-head systems and an investigational partial-knee resurfacing program.
BioPoly develops orthopedic resurfacing implants using a proprietary blend of ultrahigh molecular weight polyethylene and hyaluronic acid. Based in Fort Wayne, Indiana, the company emerged from Schwartz Biomedical and is led by founders Herb and Sheila Schwartz. Its material is designed to provide a lubricated bearing surface that articulates against remaining cartilage.
The established U.S. commercial portfolio comprises Great Toe, Lesser Toe and Radial Head implants, each supported by an FDA 510(k) clearance. Commercial milestones include first U.S. Great Toe use in 2021, Radial Head launch in 2025 and a company-announced Vizient contract covering those three implant systems.
The Partial Resurfacing Knee Implant remains investigational in the U.S. A registered randomized trial compares it with microfracture or debridement. Earlier European knee follow-up provides published clinical evidence, but its small, single-arm design and historical comparator limit conclusions about comparative effectiveness. Other joint-preservation applications remain in development.
Current U.S. marketed implants are Class II, 510(k) cleared: K203634 (Great Toe), K222964 (Lesser Toe) and K233592 (Radial Head). The knee device’s study permission and company-reported Breakthrough designation do not authorize commercial U.S. sale. Indications and fixation requirements are specific to each implant. [4][5][6][18][26][14][15][16][19][33]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [35][36]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Distal first-metatarsal resurfacing implant for labeled degenerative/post-traumatic joint conditions; consult fixation and bone-stock requirements. [25]
FDA-clearedCurrent U.S.-marketed family
Lesser-toe joint resurfacing implant with product-specific indications and fixation requirements. [22]
FDA-clearedCurrent U.S.-marketed family
Radial-head hemiarthroplasty system for labeled fracture, degenerative/post-traumatic and revision applications. [21][3]
FDA-clearedCurrent U.S.-marketed family
NCT06915363: registry status recruiting in the 2026-07-08 update; 152 participants (estimated). Study completion is estimated for 2028-12; this is not an FDA decision or commercial launch date. [17]
Company describes Bankart- and Hill-Sachs-related joint-preservation implant designs. [31]
Investigational / in developmentU.S. commercial authorization and launch not established
Company reported a patent supporting a developing Bankart-related implant. Patent and development status do not establish FDA clearance. [31]
Company reported its first U.S. investigational implantation. The press-release date is not assumed to be the exact procedure date; the registry separately lists a March 2025 study start. [29]
Company announced an Innovative Technology contract for Great Toe, Lesser Toe and Radial Head systems. Contract availability does not establish adoption by all Vizient hospitals. [27]
Company announced first elbow surgery and U.S. availability of the Radial Head system. [32]
FDA issued K233592 for the BioPoly Radial Head Implant. [4]
Company announced an exclusive VHMS distribution agreement for U.S. government healthcare agencies. Current terms and facility purchases were not independently verified. [20]
Company reported FDA Breakthrough Device designation; this is not marketing authorization. [26]
Company-funded Level IV study analyzed a 31-patient cohort; complete five-year outcomes were available for 23. The comparator came from published microfracture literature rather than concurrent randomization. [2]
FDA issued K222964 for the Lesser Toe Hemiarthroplasty Implant. [6]
Company announcement identifies a first U.S. case performed by Steve Herbst at Central Indiana Orthopedics. [19]
FDA issued K203634 for the Great Toe Hemiarthroplasty Implant. [5]
Company history dates first knee implantation in London to 2012. This is an overseas milestone, not U.S. marketing authorization. [23]
Accessed 10/29/2026