Link MP Reconstruction Hip
FDA 510(k) K955296 · Link America, Inc.
510(k) numberK955296
Submission
- Device name
- Link MP Reconstruction Hip
- Applicant
- Link America, Inc.
Indianapolis, IN, US - Received
- November 16, 1995
- Decision date
- February 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
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|---|---|---|
| K972760 | Link, Acetabular Revision Mesh CupJDJ · Traditional | 10/22/1997SE |
| K964458 | Ellis External Mini-Fixator SystemKTT · Traditional | 12/09/1996SE |
| K954186 | Sled Unicompartment Knee SystemHSX · Traditional | 01/26/1996SE |
| K931571 | Link Ceramic Heads 12/14 X 32MMLZO · Traditional | 04/19/1994SN |
| K931572 | Link Ceramic Heads 14/16 X 32MMLZO · Traditional | 03/28/1994SE |
| K920756 | Feldmuhle Ceramic HeadLZO · Traditional | 05/18/1992SE |
| K914804 | Radius Osteotomy PlatesHRS · Traditional | 04/29/1992SN |
| K914803 | Schwabe Radius PlatesHRS · Traditional | 04/28/1992SE |
| K895507 | Link Giebel Blade Plate SystemKTT · Traditional | 03/13/1990SE |
| K873507 | Link (R) American-Type Bone Staple SystemJDR · Traditional | 09/16/1987SE |
Questions and answers
When was Link MP Reconstruction Hip cleared by the FDA?
Link MP Reconstruction Hip (K955296) received a 510(k) decision of Substantially Equivalent on February 14, 1996, 90 days after the submission was received.
What is the product code of K955296?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.