Coated ZT Proximal Sleeve
FDA 510(k) K934412 · Joint Medical Products Corp.
510(k) numberK934412
Submission
- Device name
- Coated ZT Proximal Sleeve
- Applicant
- Joint Medical Products Corp.
Stamford, CT, US - Received
- September 10, 1993
- Decision date
- June 3, 1994
- 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 |
|---|---|---|
| K955511 | Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular CupLPH · Traditional | 02/26/1996SE |
| K954935 | S-Rom Femoral Hip Stem - Size 14 X 8LPH · Traditional | 01/22/1996SE |
| K944321 | S-Rom Noiles Posterior Stabilized Total Knee System IIJWH · Traditional | 08/14/1995SN |
| K951726 | S-Rom ZTP Uhmwpe Acetabular CupJDI · Traditional | 06/21/1995SE |
| K951084 | S-Rom Opc (One-Piece Cemented) II Femoral Hip ProsthesisJDI · Traditional | 05/31/1995SE |
| K951000 | ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemLPH · Traditional | 04/14/1995SE |
| K941769 | Knee ProthesisJWH · Traditional | 02/01/1995SN |
| K936037 | S-Rom Noiles Cruciate Retaining KneeJWH · Traditional | 10/03/1994SN |
| K931676 | S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole PlugJDL · Traditional | 05/18/1994SE |
| K935078 | S-Rom Total Hip Replacement SystemJDG · Traditional | 03/09/1994SN |
Questions and answers
When was Coated ZT Proximal Sleeve cleared by the FDA?
Coated ZT Proximal Sleeve (K934412) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 266 days after the submission was received.
What is the product code of K934412?
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.