Foundation Textured Stem
FDA 510(k) K952297 · Encore Orthopedics, Inc.
510(k) numberK952297
Submission
- Device name
- Foundation Textured Stem
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- May 16, 1995
- Decision date
- July 17, 1995
- 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 |
|---|---|---|
| K032905 | 3DKNEE Porous Coated Femoral ComponentMBH · Traditional | 07/06/2004SE |
| K020114 | 3D KneeJWH · Traditional | 07/12/2002SE |
| K020741 | Unicondylar KneeHRY · Traditional | 06/04/2002SE |
| K020236 | Modification to Pass Spinal SystemKWP · Special | 02/14/2002SE |
| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | 12/06/2001SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
Questions and answers
When was Foundation Textured Stem cleared by the FDA?
Foundation Textured Stem (K952297) received a 510(k) decision of Substantially Equivalent on July 17, 1995, 62 days after the submission was received.
What is the product code of K952297?
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.