Hip Joint Metal/Polymer Semi-Constrained Prothesis
FDA 510(k) K921525 · Implant Technology, Inc.
510(k) numberK921525
Submission
- Device name
- Hip Joint Metal/Polymer Semi-Constrained Prothesis
- Applicant
- Implant Technology, Inc.
Timonium, MD, US - Received
- April 3, 1992
- Decision date
- January 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K915617 | LSF Ha Coated Femoral HipMEH · Traditional | 05/28/1992SE |
| K920021 | LSF Total Hip System - Muller-Type Acetabular CupJDI · Traditional | 03/25/1992SE |
| K913616 | LSF Diagnostic Related Group Cemented HipJDI · Traditional | 11/07/1991SE |
| K902727 | LSF Cemented Femoral HipJDI · Traditional | 08/09/1990SE |
| K901460 | Lsf(Tm) Total Hip SystemJDI · Traditional | 05/22/1990SN |
| K891472 | Implant Technology Bone Cement ExtractorLZV · Traditional | 05/02/1989SE |
| K884432 | Modified LSF Total Hip SystemJDI · Traditional | 12/09/1988SE |
| K883212 | LSF (R) Total Hip System - Bipolar ComponentKXA · Traditional | 11/22/1988SE |
| K855017 | Lsf* Total Hip SystemJDI · Traditional | 06/11/1986SN |
| K841546 | Communi-Trach TubeBTO · Traditional | 04/30/1984SE |
Questions and answers
When was Hip Joint Metal/Polymer Semi-Constrained Prothesis cleared by the FDA?
Hip Joint Metal/Polymer Semi-Constrained Prothesis (K921525) received a 510(k) decision of Substantially Equivalent on January 11, 1995, 1,013 days after the submission was received.
What is the product code of K921525?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.