B-P Hemispherical Acetabular Component
FDA 510(k) K963101 · Endotec, Inc.
510(k) numberK963101
Submission
- Device name
- B-P Hemispherical Acetabular Component
- Applicant
- Endotec, Inc.
South Orange, NJ, US - Received
- August 9, 1996
- Decision date
- February 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K081400 | Fanning-Pappas Modular Knee BearingJWH · Traditional | 02/20/2009SE |
| K012702 | Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1JWH · Traditional | 01/30/2002SE |
| K992394 | Buechel-Pappas Humeral Head Resurfacing ComponentHSD · Traditional | 10/15/1999SE |
| K982418 | Buechel-Pappas Modular Salvage StemMJT · Abbreviated | 04/29/1999SE |
| K963100 | Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) Xx=Od of Ace. CupLPH · Traditional | 02/12/1997SE |
| K960425 | Buechel-Pappas Polyethlene Acetabular COMPONENT(01-42-YYXX & 01-43-YYXXJDI · Traditional | 10/03/1996SE |
| K960424 | Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=OdKWT · Traditional | 08/26/1996SE |
| K945254 | Electrosurgical Cutting & Coagulation Device AccessoriesGEI · Traditional | 06/06/1995SE |
| K944465 | Carrier, Ligature (79 Gej)GCJ · Traditional | 09/28/1994SE |
| K944414 | DekalbGCJ · Traditional | 09/27/1994SE |
Questions and answers
When was B-P Hemispherical Acetabular Component cleared by the FDA?
B-P Hemispherical Acetabular Component (K963101) received a 510(k) decision of Substantially Equivalent on February 12, 1997, 187 days after the submission was received.
What is the product code of K963101?
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.