Quatro M Femoral Component
FDA 510(k) K033313 · Whiteside Biomechanics, Inc.
510(k) numberK033313
Submission
- Device name
- Quatro M Femoral Component
- Applicant
- Whiteside Biomechanics, Inc.
Creve Coeur, MO, US - Received
- October 15, 2003
- Decision date
- July 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
More from United Orthopedic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K964616 | Quatroloc Plasma Sprayed Femoral ComponentLPH · Traditional | 08/07/1997SE |
| 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 Quatro M Femoral Component cleared by the FDA?
Quatro M Femoral Component (K033313) received a 510(k) decision of Substantially Equivalent on July 28, 2004, 287 days after the submission was received.
What is the product code of K033313?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.