Provident Hip System
FDA 510(k) K935484 · Stelkast Company
510(k) numberK935484
Submission
- Device name
- Provident Hip System
- Applicant
- Stelkast Company
Pittsburgh, PA, US - Received
- November 15, 1993
- Decision date
- June 6, 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 |
|---|---|---|
| K190276 | Provident II Hip StemLPH · Special | 03/08/2019SE |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJWH · Special | 01/19/2018SE |
| K162222 | GENflex2 Total Knee SystemJWH · Special | 09/07/2016SE |
| K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemJWH · Traditional | 08/05/2013SE |
| K122773 | Cross-Over Acetabular Shell & LinerOQG · Special | 10/09/2012SE |
| K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMOQG · Traditional | 03/24/2011SE |
| K081458 | Proven Stem ExtenderJWH · Special | 06/06/2008SE |
| K063211 | Proven Knee System High Flexion Tibial InsertJWH · Traditional | 01/18/2007SE |
| K051976 | Proven Revision Modular Tibial TrayJWH · Traditional | 10/17/2005SE |
| K033944 | Stelkast 32MM Modular Ceramic Femoral HeadLZO · Traditional | 03/12/2004SE |
Questions and answers
When was Provident Hip System cleared by the FDA?
Provident Hip System (K935484) received a 510(k) decision of Substantially Equivalent for Some Indications on June 6, 1994, 203 days after the submission was received.
What is the product code of K935484?
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.