Perfecta Femoral Stem
FDA 510(k) K031402 · Wrightmedicaltechnologyinc
510(k) numberK031402
Submission
- Device name
- Perfecta Femoral Stem
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- May 5, 2003
- Decision date
- November 22, 2004
- 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 |
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| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
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Questions and answers
When was Perfecta Femoral Stem cleared by the FDA?
Perfecta Femoral Stem (K031402) received a 510(k) decision of Substantially Equivalent on November 22, 2004, 567 days after the submission was received.
What is the product code of K031402?
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.