Prosthesis, Elbow, Hemi-, Radial, Polymer
FDA product code KWI · Class II (moderate risk) · 21 CFR 888.3170 · Orthopedic
34510(k) clearances
0PMA approvals
30recalls
Implantimplanted device
Manufacturers
- Wrightmedicaltechnologyinc 4
- Avanta Orthopaedics, Inc. 4
- Biomet, Inc. 3
- Skeletal Dynamics, Inc. 3
- In2bones USA, LLC 2
- Acumed LLC 2
- Arthrex, Inc. 1
- Lima Intl. Corp. 1
- DePuy Synthes 1
- Ignite Orthopedics, LLC 1
- Imds (Innovative MEdical Device Systems) - Leis ME 1
- Synthes (Usa) 1
- Small Bone Innovations, Inc. 1
- Kinetikos Medical, Inc. 1
- Ascension Orthopedics, Inc. 1
- Kapp Surgical Instrument, Inc. 1
- Tornier, Inc. 1
- Howmedica Osteonics Corp. 1
- DePuy Orthopaedics, Inc. 1
- Smith & Nephew, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | Arthrex, Inc. | 07/30/2026SE |
| K233592 | BioPoly Radial Head ImplantKWI · Traditional | BioPoly, LLC | 03/13/2024SE |
| K231188 | ALIGN Radial Head SystemKWI · Traditional | Skeletal Dynamics, Inc. | 09/28/2023SE |
| K213563 | DePuy Synthes Radial Head Replacement SystemKWI · Traditional | DePuy Synthes | 03/18/2022SE |
| K212872 | Avenger Radial Head SystemKWI · Traditional | In2bones USA, LLC | 12/17/2021SE |
| K192754 | Avenger Radial Head SystemKWI · Traditional | In2bones USA, LLC | 01/07/2020SE |
| K183618 | Revolution Radial HeadKWI · Traditional | Ignite Orthopedics, Inc. | 05/17/2019SE |
| K172688 | Align Radial Head SystemKWI · Special | Skeletal Dynamics, LLC | 12/22/2017SE |
| K132735 | Axia Radial Head SystemKWI · Traditional | Imds (Innovative MEdical Device Systems) - Leis ME | 01/07/2014SE |
| K131845 | Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh…KWI · Traditional | Acumed, LLC | 09/30/2013SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | Synthes USA, LLC | 06/19/2012SE |
| K092721 | Align Radial Head SystemKWI · Traditional | Skeletal Dynamics, LLC | 08/03/2010SE |
| K062898 | Sbi Lateral Rhead ImplantKWI · Traditional | Small Bone Innovations, Inc. | 11/13/2006SE |
| K060731 | Evolve Modular Radial HeadKWI · Special | Wrightmedicaltechnologyinc | 04/19/2006SE |
| K051385 | Explor Modular Radial Head Replacement DeviceKWI · Traditional | Biomet, Inc. | 08/05/2005SE |
| K041858 | Acumed Anatomic Radial Head SystemKWI · Traditional | Acumed, LLC | 10/05/2004SE |
| K040611 | Modular Radial Head Replacement DeviceKWI · Traditional | Biomet, Inc. | 06/04/2004SE |
| K032806 | Katalyst Radial Head ImplantKWI · Traditional | Kinetikos Medical, Inc. | 04/16/2004SE |
| K032686 | Ascension Modular Radial HeadKWI · Traditional | Ascension Orthopedics, Inc. | 10/22/2003SE |
| K030237 | Kapp Custom Radial Head Elbow ImplantKWI · Traditional | Kapp Surgical Instrument, Inc. | 08/29/2003SE |
| K030384 | Evolve Ceramic Radial Head ImplantKWI · Special | Wrightmedicaltechnologyinc | 08/12/2003SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | Avanta Orthopaedics, Inc. | 11/27/2002SE |
| K012551 | Liverpool Radial Head Replacement DeviceKWI · Traditional | Biomet, Inc. | 01/30/2002SE |
| K011819 | Radial Head ImplantKWI · Special | Avanta Orthopaedics, Inc. | 06/19/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | Avanta Orthopaedics, Inc. | 11/20/2000SE |
| K994041 | Tornier Bipolar Radial Head ProsthesisKWI · Traditional | Tornier, Inc. | 08/31/2000SE |
| K001385 | Howmedica Osteonics Radial Head ProthesisKWI · Traditional | Howmedica Osteonics Corp. | 07/27/2000SE |
| K000658 | Ers Radial Head ReplacementKWI · Traditional | DePuy Orthopaedics, Inc. | 05/11/2000SE |
| K992220 | Radial Head ProsthesisKWI · Abbreviated | Smith & Nephew, Inc. | 02/25/2000SE |
| K991915 | Modular Radial HeadKWI · Traditional | Wrightmedicaltechnologyinc | 09/03/1999SE |
| K984290 | Implex Radial Head Replacement SystemKWI · Traditional | Implex Corp. | 06/01/1999SE |
| K982288 | Radial Head ImplantKWI · Traditional | Avanta Orthopaedics, Inc. | 09/08/1998SE |
| K944507 | Metallic Radial Head ImplantsKWI · Traditional | Wrightmedicaltechnologyinc | 07/13/1995SN |
| K885146 | CL Universal Hip DeviceKWI · Traditional | Lima Intl. Corp. | 04/24/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0006-2023 Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE…The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm… | Wright Medical Technology, Inc. | 08/03/2022Open, Classified |
| Z-0005-2023 Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE…The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm… | Wright Medical Technology, Inc. | 08/03/2022Open, Classified |
| Z-1072-2022 Class II | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement.…DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use… | Synthes (USA) Products LLC | 04/07/2022Open, Classified |
| Z-2989-2020 Class II | EVOLVE STEM 8.5MM Model # 496S085Lack of sterility assurance | Wright Medical Technology Inc | 08/26/2020Terminated |
| Z-1102-2020 Class II | WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and… | Wright Medical Technology, Inc. | 12/27/2019Terminated |
| Z-1101-2020 Class II | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and… | Wright Medical Technology, Inc. | 12/27/2019Terminated |
| Z-2713-2018 Class II | #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2712-2018 Class II | #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2711-2018 Class II | #2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2676-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2675-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2674-2018 Class II | Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2673-2018 Class II | Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2672-2018 Class II | Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2671-2018 Class II | Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2670-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2669-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2668-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2667-2018 Class II | Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2666-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2665-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2664-2018 Class II | Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2663-2018 Class II | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-0269-2018 Class II | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed…Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to… | Zimmer Biomet, Inc. | 06/16/2017Terminated |
| Z-2197-2017 Class II | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with…The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System… | Acumed LLC | 04/20/2017Terminated |
| Z-1124-2017 Class II | Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories…There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. | Synthes (USA) Products LLC | 12/29/2016Terminated |
| Z-0582-2015 Class II | Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for…Report received where the Align Radial Stem fractured. | Skeletal Dynamics | 10/16/2014Terminated |
| Z-1615-2014 Class II | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic…This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads… | Biomet, Inc. | 04/22/2014Terminated |
| Z-0098-2014 Class II | Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial…The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the… | Small Bone Innovations, Inc. | 09/06/2013Terminated |
| Z-1238-2013 Class II | Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial…The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date… | Synthes USA HQ, Inc. | 02/22/2013Terminated |