M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.
FDA 510(k) K890054 · Protek, Inc.
510(k) numberK890054
Submission
- Device name
- M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.
- Applicant
- Protek, Inc.
Indianapolis, IN, US - Received
- January 6, 1989
- Decision date
- February 8, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K893785 | ARC-2F Acetabular CupLWJ · Traditional | 08/09/1989SN |
| K893959 | P.S.A. Femoral Hip ProsthesisKWY · Traditional | 07/25/1989SE |
| K892059 | Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional | 07/19/1989SE |
| K883794 | Resubmitted CLW Acetabular Cup W/SulmeshLWJ · Traditional | 05/26/1989SE |
| K884952 | Various Femoral Hip Prostheses W/Self Lock CeramicLZO · Traditional | 05/10/1989SE |
| K884889 | Modified O.E.C. Univ. Self-Aligning Aceta. Comp.KWL · Traditional | 02/27/1989SE |
| K884789 | New Jersey Femoral Hip Prosthesis for Cement AppliKWL · Traditional | 02/08/1989SN |
| K884888 | Modified New Jersey Acetabular Comp. & Bone ScrewsJDI · Traditional | 12/29/1988SN |
| K882671 | Samuelson Screwloc CupKWA · Traditional | 10/20/1988SE |
| K874093 | SLS-88 Total Hip System, Acetabular CupJDI · Traditional | 01/27/1988SE |
Questions and answers
When was M.E.M. Acetabular Cup W/Sulmesh for Cement Appli. cleared by the FDA?
M.E.M. Acetabular Cup W/Sulmesh for Cement Appli. (K890054) received a 510(k) decision of Substantially Equivalent for Some Indications on February 8, 1989, 33 days after the submission was received.
What is the product code of K890054?
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.