Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3720](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3720) → KWH — Prosthesis, Toe, Constrained, Polymer # KWH · Prosthesis, Toe, Constrained, Polymer _Orthopedic · 21 CFR 888.3720 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH ## Overview - **Product Code:** KWH - **Device Name:** Prosthesis, Toe, Constrained, Polymer - **Regulation:** [21 CFR 888.3720](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3720) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 21) Showing 20 most recent of 21 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K191966](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K191966.md) | NewPrim System | Brm Extremities | Feb 13, 2020 | SESE | | [K190136](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K190136.md) | Fusion Silastic System | Fusion Orthopedics, LLC | Oct 21, 2019 | SESE | | [K173491](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K173491.md) | RTS Lesser MTP Implant System | In2bones USA, LLC | Feb 23, 2018 | SESE | | [K153609](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K153609.md) | RTS Flexible 1 MPJ Implant w/Grommets | In2bones USA, LLC | Sep 8, 2016 | SESE | | [K102601](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K102601.md) | ORTHOFLEX ROD | Ortho-Pro, LLC | Jan 14, 2011 | SESE | | [K023531](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K023531.md) | LESSER METATARSAL PHALANGEAL JOINT IMPLANT | Nexa Orthopedics, Inc. | Jan 17, 2003 | SESE | | [K022887](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K022887.md) | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | Nov 26, 2002 | SESE | | [K022886](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K022886.md) | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Osteomed Corp. | Nov 25, 2002 | SESE | | [K023562](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K023562.md) | MODIFICATION TO CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Nov 13, 2002 | SESE | | [K023086](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K023086.md) | CLASSIC GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Oct 4, 2002 | SESE | | [K994326](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K994326.md) | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | Jan 7, 2000 | SESE | | [K981194](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K981194.md) | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT | Nexa Orthopedics, Inc. | Jun 30, 1998 | SESE | | [K946236](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K946236.md) | PROFIX CONFORMING PLUS TIBIAL INSERT | Smith & Nephew Richards, Inc. | Jul 6, 1995 | SESE | | [K943354](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K943354.md) | SUTTER HAMMERTOE JOINT PROSTHESIS | Sutter Corp. | Jun 12, 1995 | SESE | | [K905795](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K905795.md) | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | May 29, 1991 | SESE | | [K884739](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K884739.md) | SGARLATO LESSER TOE IMPLANT | Sgarlato Laboratories, Inc. | May 18, 1989 | SESE | | [K823405](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K823405.md) | ZIMMER GREAT TOE | Zimmer, Inc. | Jan 24, 1983 | SESE | | [K820813](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K820813.md) | LESSER METATARSAL PHALANG. JOINT PROSTH | Sutter Biomedical, Inc. | May 21, 1982 | SESE | | [K801345](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K801345.md) | KAMPNER HINGED TOE PROSTHESIS | Biomedics | Jul 8, 1980 | SESE | | [K801094](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K801094.md) | SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL | Dow Corning Corp. Healthcare Industries Materials | Jun 9, 1980 | SESE | ## Top Applicants - Nexa Orthopedics, Inc. — 4 clearances - Sgarlato Laboratories, Inc. — 2 clearances - Osteomed Corp. — 2 clearances - In2bones USA, LLC — 2 clearances - Dow Corning Corp. Healthcare Industries Materials — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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