Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3730](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3730) → KWD — Prosthesis, Toe, Hemi-, Phalangeal # KWD · Prosthesis, Toe, Hemi-, Phalangeal _Orthopedic · 21 CFR 888.3730 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD ## Overview - **Product Code:** KWD - **Device Name:** Prosthesis, Toe, Hemi-, Phalangeal - **Regulation:** [21 CFR 888.3730](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3730) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 46) Showing 20 most recent of 46 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250074](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K250074.md) | HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. | Apr 3, 2026 | SESE | | [K240268](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K240268.md) | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | Feb 29, 2024 | SESE | | [K221220](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K221220.md) | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | Apr 19, 2023 | SESE | | [K222964](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K222964.md) | BioPoly Lesser Toe Hemiarthroplasty Implant | BioPoly, LLC | Nov 22, 2022 | SESE | | [K201393](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K201393.md) | restor3d MTP Implant | Restor3D, Inc. | May 25, 2022 | SESE | | [K203634](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K203634.md) | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | Feb 2, 2021 | SESE | | [K200951](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K200951.md) | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | Dec 8, 2020 | SESE | | [K190261](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K190261.md) | BOSS Toe Fixation System | Arthrosurface, Inc. | Aug 14, 2019 | SESE | | [K190543](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K190543.md) | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | May 31, 2019 | SESE | | [K161279](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K161279.md) | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | Feb 1, 2017 | SESE | | [K152454](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K152454.md) | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | Apr 11, 2016 | SESE | | [K131377](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K131377.md) | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | Arthrosurface, Inc. | Nov 19, 2013 | SESE | | [K131187](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K131187.md) | LESSER METATARSAL HEAD IMPLANT SYSTEM | Solana Surgical, LLC | Oct 22, 2013 | SESE | | [K121973](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K121973.md) | BIOPRO HEMI-EDGE TOE SYSTEM | Biopro, Inc. | Oct 30, 2012 | SESE | | [K120029](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K120029.md) | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | Feb 6, 2012 | SESE | | [K113752](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K113752.md) | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | Solana Surgical, LLC | Feb 6, 2012 | SESE | | [K102401](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K102401.md) | HEMI IMPLANT; MINI HEMI IMPLANT | Vilex, Inc. | Jul 20, 2011 | SESE | | [K092047](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K092047.md) | ASCENSION METAL GREAT TOE SYSTEM | Ascension Orthopedics, Inc. | Jan 14, 2010 | SESE | | [K090127](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K090127.md) | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | Solana Surgical, LLC | May 1, 2009 | SESE | | [K083469](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD/K083469.md) | METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 | Metasurg | Feb 13, 2009 | SESE | ## Top Applicants - Arthrosurface, Inc. — 5 clearances - Solana Surgical, LLC — 4 clearances - Biopro, Inc. — 3 clearances - Osteomed LP — 3 clearances - Vilex, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com