Replica(Tm) Total Hip System
FDA 510(k) K926156 · Osteo Technology, Inc.
510(k) numberK926156
Submission
- Device name
- Replica(Tm) Total Hip System
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- December 7, 1992
- Decision date
- March 9, 1994
- 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 |
|---|---|---|
| K922859 | Anatomical Type Knee SystemJWH · Traditional | 09/23/1993SE |
| K922869 | Total Condylat Type Knee SystemJWH · Traditional | 07/13/1993SE |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | 06/29/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| K922870 | Three Spike CupGRF · Traditional | 04/08/1993SE |
| K925301 | Oti Orthopedic Fastener SystemHTY · Traditional | 03/16/1993SE |
| K922682 | Americana Hip ProthesisJDG · Traditional | 03/16/1993SE |
| K922871 | Unifit Femoral StemJDI · Traditional | 02/12/1993SE |
| K922868 | Thompson Type Hip ProthesisKWA · Traditional | 02/12/1993SE |
Questions and answers
When was Replica(Tm) Total Hip System cleared by the FDA?
Replica(Tm) Total Hip System (K926156) received a 510(k) decision of Substantially Equivalent for Some Indications on March 9, 1994, 457 days after the submission was received.
What is the product code of K926156?
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.