Converge Acetabular System
FDA 510(k) K012739 · Sulzer Orthopedics, Inc.
510(k) numberK012739
Submission
- Device name
- Converge Acetabular System
- Applicant
- Sulzer Orthopedics, Inc.
Austin, TX, US - Received
- August 16, 2001
- Decision date
- November 14, 2001
- 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 |
|---|---|---|
| K022985 | Ascendent Acetabular SystemLZO · Traditional | 12/05/2002SE |
| K021578 | Natural-Knee II System Cocr Tibial BaseplateJWH · Traditional | 08/09/2002SE |
| K020713 | MS-30 Lateral Femoral StemLZO · Traditional | 05/14/2002SE |
| K013935 | Allofit Acetabular System 32MM Alpha Durasul InsertsLZO · Special | 12/13/2001SE |
| K013031 | Most Options SystemKRO · Traditional | 12/07/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | 10/18/2001SE |
| K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeHSX · Traditional | 09/19/2001SE |
| K010839 | CLS Varus Stem/Cls 135 StemLZO · Special | 04/18/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | 03/07/2001SE |
| K003801 | Anatomical Press-Fit Humeral StemKWS · Traditional | 02/28/2001SE |
Questions and answers
When was Converge Acetabular System cleared by the FDA?
Converge Acetabular System (K012739) received a 510(k) decision of Substantially Equivalent on November 14, 2001, 90 days after the submission was received.
What is the product code of K012739?
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.