Quatroloc Plasma Sprayed Femoral Component
FDA 510(k) K964616 · Whiteside Biomechanics, Inc.
510(k) numberK964616
Submission
- Device name
- Quatroloc Plasma Sprayed Femoral Component
- Applicant
- Whiteside Biomechanics, Inc.
Creve Coeur, MO, US - Received
- October 24, 1996
- Decision date
- August 7, 1997
- 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 |
|---|---|---|
| K033313 | Quatro M Femoral ComponentLWJ · Traditional | 07/28/2004SE |
| K012800 | Symmetric Unicompartmental Knee SystemHRY · Traditional | 05/03/2002SE |
| K003618 | Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model BIO-1-1014NDD · Traditional | 05/23/2001SE |
| K993903 | Whiteside Biomechanics Titanium Low-Profile Cable, Model BIO-1-1013JDQ · Traditional | 02/14/2000SE |
| K991678 | Whiteside Biomechanics Spinal SystemKWQ · Traditional | 08/12/1999SE |
| K981238 | Bipolar Femoral HeadKWY · Traditional | 08/21/1998SE |
| K973261 | Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral HeadLZO · Traditional | 11/24/1997SE |
| K971721 | Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral HeadLZO · Traditional | 07/30/1997SE |
| K971718 | Micro-Seal Acetabular SystemLPH · Traditional | 07/23/1997SE |
| K964150 | Whiteside Biomechanics Zirconia Ceramic Femoral HeadLZO · Traditional | 12/27/1996SE |
Questions and answers
When was Quatroloc Plasma Sprayed Femoral Component cleared by the FDA?
Quatroloc Plasma Sprayed Femoral Component (K964616) received a 510(k) decision of Substantially Equivalent on August 7, 1997, 287 days after the submission was received.
What is the product code of K964616?
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.