Prosthesis, Elbow, Semi-Constrained, Cemented
FDA product code JDB · Class II (moderate risk) · 21 CFR 888.3160 · Orthopedic
27510(k) clearances
0PMA approvals
24recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222807 | TEMA Elbow system - Line extensionJDB · Traditional | Lima Corporate S.P.A. | 10/26/2022SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/05/2020SE |
| K182461 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 12/27/2018SE |
| K171010 | Latitude EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/31/2017SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | Small Bone Innovations, Inc. | 12/20/2010SE |
| K100562 | Latitude Elbow ProsthesisJDB · Special | Tornier, Inc. | 06/29/2010SE |
| K070787 | Latitude Elbow ProthesisJDB · Special | Tornier | 08/24/2007SE |
| K070236 | Sbi Lateral Radio CapitellumJDB · Special | Small Bone Innovations, Inc. | 02/21/2007SE |
| K060438 | RHSJDB · Traditional | Tornier | 04/18/2006SE |
| K060038 | Sbi Radio-Capitellar ImplantJDB · Traditional | Small Bone Innovations, Inc. | 03/30/2006SE |
| K050848 | Tornier Elbow ProsthesisJDB · Traditional | Tornier | 07/14/2005SE |
| K031218 | Modification to Tornier Total Elbow ProsthesisJDB · Special | Tornier | 05/16/2003SE |
| K011567 | Tornier Total Elbow ProsthesisJDB · Special | Tornier | 06/19/2001SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | Johnson & Johnson Professionals, Inc. | 11/06/1998SE |
| K972691 | Abc Total Elbow ProthesisJDB · Traditional | Biomet, Inc. | 10/15/1997SE |
| K960087 | Soribie Resurfacing Total Elbow System (Proposed Name)JDB · Traditional | Wrightmedicaltechnologyinc | 09/20/1996SE |
| K955099 | Sorbie Total Elbow SystemJDB · Traditional | Wrightmedicaltechnologyinc | 02/05/1996SE |
| K880188 | Souter Strathclyde Total Elbow SystemJDB · Traditional | Howmedica Corp. | 03/01/1988SE |
| K873660 | Roper-Tuke ElbowJDB · Traditional | Orthopedic Systems, Inc. | 01/06/1988SN |
| K823473 | Porocoat Mark IV ElbowJDB · Traditional | Depuy, Inc. | 01/20/1983SE |
| K820957 | Suface Replacement ElbowJDB · Traditional | Howmedica Corp. | 07/02/1982SE |
| K812322 | Arizona Radio Capitellar Total ElbowJDB · Traditional | Zimmer, Inc. | 01/04/1982SE |
| K811451 | Radial Head ProsthesisJDB · Traditional | Cintor Orthopaedic Div. | 06/09/1981SE |
| K810847 | Pritchard Surface Replacement ElbowJDB · Traditional | Depuy, Inc. | 05/01/1981SE |
| K802348 | TriaxialJDB · Traditional | Johnson & Johnson Professionals, Inc. | 02/23/1981SE |
| K802460 | Helfet Elbow ProsthesisJDB · Traditional | Depuy, Inc. | 11/19/1980SE |
| K801574 | Depalma ElbowJDB · Traditional | Zimmer, Inc. | 10/31/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1651-2025 Class II | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF…A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked:… | Tornier, Inc | 03/03/2025Open, Classified |
| Z-0744-2025 Class II | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA…Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during… | Limacorporate S.p.A | 10/02/2024Open, Classified |
| Z-2710-2018 Class II | Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2709-2018 Class II | rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2708-2018 Class II | rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2707-2018 Class II | rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2706-2018 Class II | rHead Standard Extended Stem, 6mm Collar, 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-2705-2018 Class II | rHead Standard Extended Stem, 6mm Collar, 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-2704-2018 Class II | rHead Standard Extended Stem, 6mm Collar, 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-2703-2018 Class II | rHead Standard Extended Stem, 6mm Collar, Size 1. 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-2702-2018 Class II | Radio Capitellum, Recon Head, 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-2701-2018 Class II | Radio Capitellum, Recon Head, 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-2700-2018 Class II | Radio Capitellum, Recon Head, 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-2699-2018 Class II | Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2698-2018 Class II | Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2697-2018 Class II | Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2696-2018 Class II | Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2695-2018 Class II | Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2694-2018 Class II | Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2693-2018 Class II | Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of…Revision rate identified as higher than other proximal radial head replacement devices based on literature… | Howmedica Osteonics Corp. | 10/24/2017Terminated |
| Z-2429-2015 Class II | Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended…Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity… | Stryker Howmedica Osteonics Corp. | 06/24/2015Terminated |
| Z-2428-2015 Class II | Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in…Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity… | Stryker Howmedica Osteonics Corp. | 06/24/2015Terminated |
| Z-2426-2015 Class II | rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the…Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity… | Stryker Howmedica Osteonics Corp. | 06/24/2015Terminated |
| Z-3082-2011 | Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented…Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral… | Tornier, Inc | 06/23/2011Terminated |