Conformis Bicompartmental Knee Repair System
FDA 510(k) K053488 · Conformis, Inc.
510(k) numberK053488
Submission
- Device name
- Conformis Bicompartmental Knee Repair System
- Applicant
- Conformis, Inc.
Foster City, CA, US - Received
- December 15, 2005
- Decision date
- March 9, 2006
- 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 |
| 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 |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…MBH · Special | 09/08/2023SE |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…MBH · Traditional | 07/21/2023SE |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemJWH · Traditional | 07/17/2023SE |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRSJWH · Special | 05/26/2023SE |
| K231178 | ACTERA hip systemMEH · Special | 05/23/2023SE |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…JWH · Special | 04/27/2023SE |
| K221104 | Actera hip systemMEH · Traditional | 08/04/2022SE |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Traditional | 07/26/2022SE |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior…JWH · Special | 05/10/2022SE |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…JWH · Special | 11/10/2021SE |
Questions and answers
When was Conformis Bicompartmental Knee Repair System cleared by the FDA?
Conformis Bicompartmental Knee Repair System (K053488) received a 510(k) decision of Substantially Equivalent on March 9, 2006, 84 days after the submission was received.
What is the product code of K053488?
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.