JDB · Prosthesis, Elbow, Semi-Constrained, Cemented
Orthopedic · 21 CFR 888.3160 · Class 2
Overview
| Product Code | JDB |
|---|---|
| Device Name | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Regulation | 21 CFR 888.3160 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (27)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | Oct 26, 2022 | SESE |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | Aug 5, 2020 | SESE |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | Dec 27, 2018 | SESE |
| K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | Aug 31, 2017 | SESE |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Small Bone Innovations, Inc. | Dec 20, 2010 | SESE |
| K100562 | LATITUDE ELBOW PROSTHESIS | Tornier, Inc. | Jun 29, 2010 | SESE |
| K070787 | LATITUDE ELBOW PROTHESIS | Tornier | Aug 24, 2007 | SESE |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Small Bone Innovations, Inc. | Feb 21, 2007 | SESE |
| K060438 | RHS | Tornier | Apr 18, 2006 | SESE |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Small Bone Innovations, Inc. | Mar 30, 2006 | SESE |
| K050848 | TORNIER ELBOW PROSTHESIS | Tornier | Jul 14, 2005 | SESE |
| K031218 | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | Tornier | May 16, 2003 | SESE |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | Jun 19, 2001 | SESE |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Johnson & Johnson Professionals, Inc. | Nov 6, 1998 | SESE |
| K972691 | ABC TOTAL ELBOW PROTHESIS | Biomet, Inc. | Oct 15, 1997 | SESE |
| K960087 | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | Wrightmedicaltechnologyinc | Sep 20, 1996 | SESE |
| K955099 | SORBIE TOTAL ELBOW SYSTEM | Wrightmedicaltechnologyinc | Feb 5, 1996 | SESE |
| K880188 | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM | Howmedica Corp. | Mar 1, 1988 | SESE |
| K873660 | ROPER-TUKE ELBOW | Orthopedic Systems, Inc. | Jan 6, 1988 | SN |
| K823473 | POROCOAT MARK IV ELBOW | Depuy, Inc. | Jan 20, 1983 | SESE |
| K820957 | SUFACE REPLACEMENT ELBOW | Howmedica Corp. | Jul 2, 1982 | SESE |
| K812322 | ARIZONA RADIO CAPITELLAR TOTAL ELBOW | Zimmer, Inc. | Jan 4, 1982 | SESE |
| K811451 | RADIAL HEAD PROSTHESIS | Cintor Orthopaedic Div. | Jun 9, 1981 | SESE |
| K810847 | PRITCHARD SURFACE REPLACEMENT ELBOW | Depuy, Inc. | May 1, 1981 | SESE |
| K802348 | TRIAXIAL | Johnson & Johnson Professionals, Inc. | Feb 23, 1981 | SESE |
| K802460 | HELFET ELBOW PROSTHESIS | Depuy, Inc. | Nov 19, 1980 | SESE |
| K801574 | DEPALMA ELBOW | Zimmer, Inc. | Oct 31, 1980 | SESE |
Top Applicants
- Tornier — 5 clearances
- Tornier, Inc. — 4 clearances
- Small Bone Innovations, Inc. — 3 clearances
- Depuy, Inc. — 3 clearances
- Zimmer, Inc. — 2 clearances
