Tri-Fit Femoral Stem
FDA 510(k) K010243 · Corin USA
510(k) numberK010243
Submission
- Device name
- Tri-Fit Femoral Stem
- Applicant
- Corin USA
Tampa, FL, US - Received
- January 25, 2001
- Decision date
- February 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K203751 | OMNIVision systemOLO · Traditional | 04/12/2021SE |
| K202805 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 11/20/2020SE |
| K193545 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 08/04/2020SE |
| K193042 | Optimized Positioning System (OPS) ReViewLLZ · Traditional | 06/26/2020SE |
| K192656 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 05/01/2020SE |
| K190143 | LARS AC Band DeviceHTN · Traditional | 11/04/2019SE |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO · Traditional | 07/22/2019SE |
| K183038 | Corin Optimized Positioning System (OPS) PlanLLZ · Traditional | 11/26/2018SE |
| K181061 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 09/07/2018SE |
| K152893 | Corin Optimized Positioning System (OPS)LZO · Traditional | 06/03/2016SE |
Questions and answers
When was Tri-Fit Femoral Stem cleared by the FDA?
Tri-Fit Femoral Stem (K010243) received a 510(k) decision of Substantially Equivalent on February 15, 2001, 21 days after the submission was received.
What is the product code of K010243?
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.