Prosthesis, Elbow, Semi-Constrained, Cemented
A semi-constrained cemented elbow prosthesis is an implantable joint replacement device that replaces the elbow articulation with linked metal and polymer components fixed with bone cement, allowing controlled range of motion while providing stability for patients with severe arthritis, trauma, or other elbow joint pathology. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDB, regulated under 21 CFR 888.3160, within the Orthopedic medical specialty. This device is an implant.
Basic Information
- Product Code
- JDB
- Device Class
- FDA class 2
- Regulation Number
- 888.3160
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222807 | TEMA Elbow system - Line extension | Oct 26, 2022 | Substantially Equivalent | LimaCorporate S.p.A. |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | Aug 05, 2020 | Substantially Equivalent | Tornier Inc. |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Dec 27, 2018 | Substantially Equivalent | Tornier Inc. |
| K171010 | Latitude EV Total Elbow Arthroplasty | Aug 31, 2017 | Substantially Equivalent | Tornier Inc. |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Dec 20, 2010 | Substantially Equivalent | SMALL BONE INNOVATIONS, INC. |
| K100562 | LATITUDE ELBOW PROSTHESIS | Jun 29, 2010 | Substantially Equivalent | TORNIER, INC. |
| K070787 | LATITUDE ELBOW PROTHESIS | Aug 24, 2007 | Substantially Equivalent | TORNIER |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Feb 21, 2007 | Substantially Equivalent | SMALL BONE INNOVATIONS, INC. |
| K060438 | RHS | Apr 18, 2006 | Substantially Equivalent | TORNIER |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Mar 30, 2006 | Substantially Equivalent | SMALL BONE INNOVATIONS INC. |
| K050848 | TORNIER ELBOW PROSTHESIS | Jul 14, 2005 | Substantially Equivalent | TORNIER |
| K031218 | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | May 16, 2003 | Substantially Equivalent | TORNIER |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Jun 19, 2001 | Substantially Equivalent | TORNIER |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 06, 1998 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K972691 | ABC TOTAL ELBOW PROTHESIS | Oct 15, 1997 | Substantially Equivalent | BIOMET, INC. |
| K960087 | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | Sep 20, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K955099 | SORBIE TOTAL ELBOW SYSTEM | Feb 05, 1996 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K880188 | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM | Mar 01, 1988 | Substantially Equivalent | HOWMEDICA CORP. |
| K873660 | ROPER-TUKE ELBOW | Jan 06, 1988 | Substantially Equivalent for Some Indications | ORTHOPEDIC SYSTEMS, INC. |
| K823473 | POROCOAT MARK IV ELBOW | Jan 20, 1983 | Substantially Equivalent | DEPUY, INC. |
| K820957 | SUFACE REPLACEMENT ELBOW | Jul 02, 1982 | Substantially Equivalent | HOWMEDICA CORP. |
| K812322 | ARIZONA RADIO CAPITELLAR TOTAL ELBOW | Jan 04, 1982 | Substantially Equivalent | ZIMMER, INC. |
| K811451 | RADIAL HEAD PROSTHESIS | Jun 09, 1981 | Substantially Equivalent | CINTOR ORTHOPAEDIC DIV. |
| K810847 | PRITCHARD SURFACE REPLACEMENT ELBOW | May 01, 1981 | Substantially Equivalent | DEPUY, INC. |
| K802348 | TRIAXIAL | Feb 23, 1981 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K802460 | HELFET ELBOW PROSTHESIS | Nov 19, 1980 | Substantially Equivalent | DEPUY, INC. |
| K801574 | DEPALMA ELBOW | Oct 31, 1980 | Substantially Equivalent | ZIMMER, INC. |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.