Prosthesis, Wrist, Carpal Trapezium
FDA product code KYI · Class II (moderate risk) · 21 CFR 888.3770 · Orthopedic
26510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Wrightmedicaltechnologyinc 4
- Ascension Orthopedics, Inc. 3
- Artimplant AB 3
- Dow Corning Wright 2
- Avanta Orthopaedics, Inc. 2
- Biopro, Inc. 2
- Skeletal Dynamics, Inc. 2
- Dow Corning Corp. Healthcare Industries Materials 1
- Scientific Data Systems Israel, Ltd. 1
- B.H. Richardson, D.C. 1
- Biologically Oriented Prostheses 1
- Nexa Orthopedics, Inc. 1
- Extremity Medical, LLC 1
- Ascension Orthopedic 1
- Ensemble Orthopedics, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161KYI · Traditional | Ensemble Orthopedics, LLC | 12/02/2020SE |
| K180744 | Stablyx CMC Arthroplasty Implant SystemKYI · Special | Skeletal Dynamics, LLC | 04/11/2018SE |
| K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5KYI · Traditional | Skeletal Dynamics, LLC | 12/30/2011SE |
| K112278 | Ascension Nugrip CMC ImplantKYI · Traditional | Ascension Orthopedic | 11/04/2011SE |
| K092548 | Extremity Medical Trapezium ProsthesisKYI · Traditional | Extremity Medical, LLC | 12/15/2009SE |
| K061956 | Artelon STT SpacerKYI · Traditional | Artimplant AB | 06/07/2007SE |
| K061954 | Artelon CMC Spacer ArthroKYI · Special | Artimplant AB | 06/01/2007SE |
| K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40KYI · Traditional | Ascension Orthopedics, Inc. | 08/11/2006SE |
| K061089 | Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYI · Traditional | Biopro, Inc. | 06/20/2006SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | Nexa Orthopedics, Inc. | 05/10/2006SE |
| K052596 | Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240…KYI · Traditional | Biopro, Inc. | 11/15/2005SE |
| K042690 | Ascension Pyrosphere (PCS)KYI · Traditional | Ascension Orthopedics, Inc. | 11/13/2004SE |
| K040070 | Artelon Spacer CMC-1KYI · Traditional | Artimplant AB | 09/21/2004SE |
| K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…KYI · Traditional | Ascension Orthopedics, Inc. | 08/25/2004SE |
| K033529 | Tie-In TrapeziumKYI · Special | Wrightmedicaltechnologyinc | 12/03/2003SE |
| K965204 | Avanta Orthopaedics Trapezium ImplantKYI · Traditional | Avanta Orthopaedics, Inc. | 06/03/1997SN |
| K960659 | Ceramic Spherical CMC Implant (Subject to Marketing Approval)KYI · Traditional | Wrightmedicaltechnologyinc | 02/06/1997SE |
| K960534 | Metallic Spherical CMC ImplantKYI · Traditional | Wrightmedicaltechnologyinc | 02/06/1997SE |
| K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentKYI · Traditional | Biologically Oriented Prostheses | 02/03/1997SE |
| K964381 | Avanta Orthopaedics Trapezial ImplantKYI · Traditional | Avanta Orthopaedics, Inc. | 01/22/1997SE |
| K951471 | Strickland Trapezial ImplantKYI · Traditional | Wrightmedicaltechnologyinc | 08/09/1995SE |
| K864489 | Swanson Titanium Trapezium ImplantKYI · Traditional | Dow Corning Wright | 04/15/1987SE |
| K864488 | Swanson Titanium Condylar ImplantKYI · Traditional | Dow Corning Wright | 04/15/1987SE |
| K801952 | Spine AlignKYI · Traditional | B.H. Richardson, D.C. | 09/16/1980SE |
| K790508 | Trapezio-Metacarpal Joint SpacerKYI · Traditional | Scientific Data Systems Israel, Ltd. | 04/10/1979SE |
| K781756 | Silastic H.P. Trapexial ImplantKYI · Traditional | Dow Corning Corp. Healthcare Industries Materials | 11/15/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0572-2020 Class II | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002The firm discovered a lack of adequate documentation confirming sterility on certain products. | Wright Medical Technology, Inc. | 11/08/2016Terminated |
| Z-1568-2013 Class III | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of…As a result of a quality review, labelling content discrepancies were identified between the Instruction for… | Integra LifeSciences Corp. | 06/03/2013Terminated |
| Z-0438-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog…Two different product lots were found to be incorrectly labeled and placed into the incorrect box. | Ascension Orthopedics, Inc | 07/12/2010Terminated |
| Z-0437-2011 | The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L, Catalog…Two different product lots were found to be incorrectly labeled and placed into the incorrect box. | Ascension Orthopedics, Inc | 07/12/2010Terminated |