KWI · Prosthesis, Elbow, Hemi-, Radial, Polymer
Orthopedic · 21 CFR 888.3170 · Class 2
Overview
| Product Code | KWI |
|---|---|
| Device Name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Regulation | 21 CFR 888.3170 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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 | BioPoly Radial Head Implant | BioPoly, LLC | Mar 13, 2024 | SESE |
| K231188 | ALIGN Radial Head System | Skeletal Dynamics, Inc. | Sep 28, 2023 | SESE |
| K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | Mar 18, 2022 | SESE |
| K212872 | Avenger Radial Head System | In2bones USA, LLC | Dec 17, 2021 | SESE |
| K192754 | Avenger Radial Head System | In2bones USA, LLC | Jan 7, 2020 | SESE |
| K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | May 17, 2019 | SESE |
| K172688 | Align Radial Head System | Skeletal Dynamics, LLC | Dec 22, 2017 | SESE |
| K132735 | AXIA RADIAL HEAD SYSTEM | Imds (Innovative MEdical Device Systems) - Leis ME | Jan 7, 2014 | SESE |
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | Acumed, LLC | Sep 30, 2013 | SESE |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | Synthes USA, LLC | Jun 19, 2012 | SESE |
| K092721 | ALIGN RADIAL HEAD SYSTEM | Skeletal Dynamics, LLC | Aug 3, 2010 | SESE |
| K062898 | SBI LATERAL RHEAD IMPLANT | Small Bone Innovations, Inc. | Nov 13, 2006 | SESE |
| K060731 | EVOLVE MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | Apr 19, 2006 | SESE |
| K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | Aug 5, 2005 | SESE |
| K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | Acumed, LLC | Oct 5, 2004 | SESE |
| K040611 | MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | Jun 4, 2004 | SESE |
| K032806 | KATALYST RADIAL HEAD IMPLANT | Kinetikos Medical, Inc. | Apr 16, 2004 | SESE |
| K032686 | ASCENSION MODULAR RADIAL HEAD | Ascension Orthopedics, Inc. | Oct 22, 2003 | SESE |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Kapp Surgical Instrument, Inc. | Aug 29, 2003 | SESE |
| K030384 | 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
