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.
Cleared Devices (33)
| 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 |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | Nov 27, 2002 | SESE |
| K012551 | LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | Jan 30, 2002 | SESE |
| K011819 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | Jun 19, 2001 | SESE |
| K002644 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | Nov 20, 2000 | SESE |
| K994041 | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS | Tornier, Inc. | Aug 31, 2000 | SESE |
| K001385 | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS | Howmedica Osteonics Corp. | Jul 27, 2000 | SESE |
| K000658 | ERS RADIAL HEAD REPLACEMENT | DePuy Orthopaedics, Inc. | May 11, 2000 | SESE |
| K992220 | RADIAL HEAD PROSTHESIS | Smith & Nephew, Inc. | Feb 25, 2000 | SESE |
| K991915 | MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | Sep 3, 1999 | SESE |
| K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM | Implex Corp. | Jun 1, 1999 | SESE |
| K982288 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | Sep 8, 1998 | SESE |
| K944507 | METALLIC RADIAL HEAD IMPLANTS | Wrightmedicaltechnologyinc | Jul 13, 1995 | SN |
| K885146 | CL UNIVERSAL HIP DEVICE | Lima Intl. Corp. | Apr 24, 1989 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 4 clearances
- Avanta Orthopaedics, Inc. — 4 clearances
- Biomet, Inc. — 3 clearances
- Skeletal Dynamics, LLC — 2 clearances
- In2bones USA, LLC — 2 clearances
