New Jersey Femoral Hip Prosthesis for Cement Appli
FDA 510(k) K884789 · Protek, Inc.
510(k) numberK884789
Submission
- Device name
- New Jersey Femoral Hip Prosthesis for Cement Appli
- Applicant
- Protek, Inc.
Indianapolis, IN, US - Received
- November 15, 1988
- Decision date
- February 8, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | Osteoremedies, LLC | 07/24/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | Depuy Ireland UC | 05/15/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 12/23/2025SE |
| K252326 | InterSpace GV Hip SpacerKWL · Special | Tecres S.P.A. | 08/06/2025SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | Heraeus Medical GmbH | 02/15/2024SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
More from Osteoremedies, LLC
| 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 |
| K890054 | M.E.M. Acetabular Cup W/Sulmesh for Cement Appli.JDI · 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 New Jersey Femoral Hip Prosthesis for Cement Appli cleared by the FDA?
New Jersey Femoral Hip Prosthesis for Cement Appli (K884789) received a 510(k) decision of Substantially Equivalent for Some Indications on February 8, 1989, 85 days after the submission was received.
What is the product code of K884789?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.