Various Uhmwp Hip & Knee Joint Prosthesis Modified
FDA 510(k) K951356 · Biologically Oriented Prostheses
510(k) numberK951356
Submission
- Device name
- Various Uhmwp Hip & Knee Joint Prosthesis Modified
- Applicant
- Biologically Oriented Prostheses
Port Huron, MI, US - Received
- March 24, 1995
- Decision date
- June 19, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K002325 | Wujin #3 Tibial NailJDS · Traditional | 10/30/2000SE |
| K992144 | Biopro Rimmed Acetabular CompomentLZO · Traditional | 09/22/1999SE |
| K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentKYI · Traditional | 02/03/1997SE |
| K962769 | Horizon Hip SystemLPH · Traditional | 10/03/1996SE |
| K955916 | Townley Total Elbow SystemJDC · Traditional | 08/08/1996SE |
| K954768 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 01/18/1996SE |
| K952731 | Townley All Poly Acetabular CupJDI · Traditional | 12/28/1995SE |
| K953045 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 09/27/1995SN |
Questions and answers
When was Various Uhmwp Hip & Knee Joint Prosthesis Modified cleared by the FDA?
Various Uhmwp Hip & Knee Joint Prosthesis Modified (K951356) received a 510(k) decision of Substantially Equivalent for Some Indications on June 19, 1995, 87 days after the submission was received.
What is the product code of K951356?
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.