Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3170](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3170) → KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer # KWI · Prosthesis, Elbow, Hemi-, Radial, Polymer _Orthopedic · 21 CFR 888.3170 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI ## Overview - **Product Code:** KWI - **Device Name:** Prosthesis, Elbow, Hemi-, Radial, Polymer - **Regulation:** [21 CFR 888.3170](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3170) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 33) Showing 20 most recent of 33 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233592](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K233592.md) | BioPoly Radial Head Implant | BioPoly, LLC | Mar 13, 2024 | SESE | | [K231188](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K231188.md) | ALIGN Radial Head System | Skeletal Dynamics, Inc. | Sep 28, 2023 | SESE | | [K213563](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K213563.md) | DePuy Synthes Radial Head Replacement System | DePuy Synthes | Mar 18, 2022 | SESE | | [K212872](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K212872.md) | Avenger Radial Head System | In2bones USA, LLC | Dec 17, 2021 | SESE | | [K192754](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K192754.md) | Avenger Radial Head System | In2bones USA, LLC | Jan 7, 2020 | SESE | | [K183618](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K183618.md) | Revolution Radial Head | Ignite Orthopedics, Inc. | May 17, 2019 | SESE | | [K172688](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K172688.md) | Align Radial Head System | Skeletal Dynamics, LLC | Dec 22, 2017 | SESE | | [K132735](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K132735.md) | AXIA RADIAL HEAD SYSTEM | Imds (Innovative MEdical Device Systems) - Leis ME | Jan 7, 2014 | SESE | | [K131845](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K131845.md) | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | Acumed, LLC | Sep 30, 2013 | SESE | | [K112030](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K112030.md) | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | Synthes USA, LLC | Jun 19, 2012 | SESE | | [K092721](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K092721.md) | ALIGN RADIAL HEAD SYSTEM | Skeletal Dynamics, LLC | Aug 3, 2010 | SESE | | [K062898](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K062898.md) | SBI LATERAL RHEAD IMPLANT | Small Bone Innovations, Inc. | Nov 13, 2006 | SESE | | [K060731](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K060731.md) | EVOLVE MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | Apr 19, 2006 | SESE | | [K051385](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K051385.md) | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | Aug 5, 2005 | SESE | | [K041858](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K041858.md) | ACUMED ANATOMIC RADIAL HEAD SYSTEM | Acumed, LLC | Oct 5, 2004 | SESE | | [K040611](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K040611.md) | MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | Jun 4, 2004 | SESE | | [K032806](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K032806.md) | KATALYST RADIAL HEAD IMPLANT | Kinetikos Medical, Inc. | Apr 16, 2004 | SESE | | [K032686](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K032686.md) | ASCENSION MODULAR RADIAL HEAD | Ascension Orthopedics, Inc. | Oct 22, 2003 | SESE | | [K030237](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K030237.md) | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Kapp Surgical Instrument, Inc. | Aug 29, 2003 | SESE | | [K030384](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI/K030384.md) | EVOLVE CERAMIC RADIAL HEAD IMPLANT | Wrightmedicaltechnologyinc | Aug 12, 2003 | SESE | ## Top Applicants - Avanta Orthopaedics, Inc. — 4 clearances - Wrightmedicaltechnologyinc — 4 clearances - Biomet, Inc. — 3 clearances - Acumed, LLC — 2 clearances - In2bones USA, LLC — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWI) **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