Nexflex Total Hip System
FDA 510(k) K042252 · Alphatec/Nexmed
510(k) numberK042252
Submission
- Device name
- Nexflex Total Hip System
- Applicant
- Alphatec/Nexmed
Carlsbad, CA, US - Received
- August 20, 2004
- Decision date
- December 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K050830 | Zodiac Spinal Fixation SystemKWP · Traditional | 06/22/2005SE |
| K051286 | Zodiac Spinal Fixation SystemMNH · Special | 06/17/2005SE |
| K050553 | Novel VBR Spinal SystemMQP · Special | 04/18/2005SE |
| K050390 | Tamarack Anterior ThoracolunbarKWQ · Traditional | 03/14/2005SE |
| K050078 | Roc Lumbar Plating SystemMNH · Traditional | 02/18/2005SE |
| K042673 | Zodiac Polyaxial Spinal Fixation SystemKWP · Special | 10/27/2004SE |
| K042440 | Alphatec Femoral Trochanteric Nail (FTN) SystemHSB · Traditional | 10/07/2004SE |
| K042201 | Novel VBR Spinal SystemMQP · Traditional | 10/07/2004SE |
Questions and answers
When was Nexflex Total Hip System cleared by the FDA?
Nexflex Total Hip System (K042252) received a 510(k) decision of Substantially Equivalent on December 6, 2004, 108 days after the submission was received.
What is the product code of K042252?
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.