Plus-Fit Acetabular Cup
FDA 510(k) K973077 · Plus Orthopedics
510(k) numberK973077
Submission
- Device name
- Plus-Fit Acetabular Cup
- Applicant
- Plus Orthopedics
Foster City, CA, US - Received
- August 18, 1997
- Decision date
- November 13, 1997
- 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 |
|---|---|---|
| K070928 | Ceramic Ball Heads, 28, 32 and 36 MMLZO · Traditional | 08/01/2007SE |
| K070731 | Pigalileo Total Hip Replacement (THR) SystemHAW · Traditional | 07/31/2007SE |
| K070278 | Polarcup Dual Mobility SystemLPH · Traditional | 04/16/2007SE |
| K063578 | Promos Modular Shoulder SystemHSD · Traditional | 03/02/2007SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | 10/06/2006SE |
| K032126 | Promos ShoulderHSD · Traditional | 01/08/2004SE |
| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
| K032215 | Vks/Tc-Plus Revision KneeJWH · Special | 08/08/2003SE |
Questions and answers
When was Plus-Fit Acetabular Cup cleared by the FDA?
Plus-Fit Acetabular Cup (K973077) received a 510(k) decision of Substantially Equivalent on November 13, 1997, 87 days after the submission was received.
What is the product code of K973077?
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.