Smith & Nephew Competitor Deuce Femoral Components
FDA 510(k) K061569 · Smith & Nephew, Inc.
510(k) numberK061569
Submission
- Device name
- Smith & Nephew Competitor Deuce Femoral Components
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- June 6, 2006
- Decision date
- July 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
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|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corp. | 03/10/2015SE |
| K133039 | Restoris Multicompartmental Knee SystemNPJ · Special | Mako Surgical Corporation | 12/10/2013SE |
| K093513 | Iduo Bicompartmental Knee Repair SystemNPJ · Special | Conformis, Inc. | 12/16/2009SE |
| K093056 | Smith & Nephew, Inc. Journey Select Knee SystemNPJ · Traditional | Smith & Nephew, Inc. | 12/15/2009SE |
| K090763 | Restoris Multicompartmental Knee (MCK) SystemNPJ · Traditional | Mako Surgical Corporation | 06/17/2009SE |
| K070849 | Depuy GCK Femoral and Tibial ComponentsNPJ · Traditional | DePuy Orthopaedics, Inc. | 06/26/2007SE |
| K061648 | Depuy Graduated Compartmental Knee (GCK)NPJ · Traditional | DePuy Orthopaedics, Inc. | 09/11/2006SE |
| K053488 | Conformis Bicompartmental Knee Repair SystemNPJ · Traditional | Conformis, Inc. | 03/09/2006SE |
| K052917 | Stryker Compartmental Knee SystemNPJ · Traditional | Howmedica Osteonics Corp. | 12/27/2005SE |
| K052265 | Smith & Nephew Competitor Duo Knee FemoralNPJ · Abbreviated | Smith & Nephew, Inc. | 12/27/2005SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
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Questions and answers
When was Smith & Nephew Competitor Deuce Femoral Components cleared by the FDA?
Smith & Nephew Competitor Deuce Femoral Components (K061569) received a 510(k) decision of Substantially Equivalent on July 6, 2006, 30 days after the submission was received.
What is the product code of K061569?
The FDA product code is NPJ – Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.