Stryker Compartmental Knee System
FDA 510(k) K052917 · Howmedica Osteonics Corp.
510(k) numberK052917
Submission
- Device name
- Stryker Compartmental Knee System
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- October 17, 2005
- Decision date
- December 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
Other 510(k)s with product code NPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K061569 | Smith & Nephew Competitor Deuce Femoral ComponentsNPJ · Special | Smith & Nephew, Inc. | 07/06/2006SE |
| K053488 | Conformis Bicompartmental Knee Repair SystemNPJ · Traditional | Conformis, Inc. | 03/09/2006SE |
| K052265 | Smith & Nephew Competitor Duo Knee FemoralNPJ · Abbreviated | Smith & Nephew, Inc. | 12/27/2005SE |
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| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI · Traditional | 08/13/2020SE |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…MBH · Traditional | 05/13/2020SE |
| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | 12/27/2013SE |
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | 08/16/2013SE |
| K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…KRO · Traditional | 02/22/2013SE |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | 03/29/2012SE |
Questions and answers
When was Stryker Compartmental Knee System cleared by the FDA?
Stryker Compartmental Knee System (K052917) received a 510(k) decision of Substantially Equivalent on December 27, 2005, 71 days after the submission was received.
What is the product code of K052917?
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.