Company ยท US
Consensus Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2017. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 1 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 2017 | K170344 | Tahoe Uni Knee System Consensus Orthopedics, Inc. | HSX |
| Aug 9, 2017 | K163167 | CKS Plus Knee System Consensus Orthopedics, Inc. | JWH |
| Dec 19, 2016 | K160515 | PS2 Knee System Consensus Orthopedics, Inc. | JWH |
| Mar 4, 2015 | K143725 | Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc. | JWH |
| Jul 14, 2014 | K133919 | CONSENSUS VITALITE TIBIAL INSERT Consensus Orthopedics, Inc. | JWH |
| May 19, 2014 | K141043 | CS2 MULTI-HOLE ACETABULAR SHELL Consensus Orthopedics, Inc. | LPH |
| Dec 17, 2013 | K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT Consensus Orthopedics, Inc. | OQG |
| Nov 5, 2012 | K122512 | CS2 HIP SYSTEM Consensus Orthopedics, Inc. | LPH |
| Oct 12, 2012 | K120595 | UNISYN PLUS HIP STEM Consensus Orthopedics, Inc. | LWJ |
| Sep 10, 2012 | K121935 | TAPERSET HIP SMALL STEMS Consensus Orthopedics, Inc. | LPH |
| May 22, 2012 | K121263 | TAPER SET HIP SYSTEM RDP STEM Consensus Orthopedics, Inc. | LPH |
| Jun 27, 2011 | K110950 | CONSENSUS KNEE SYSTEM Consensus Orthopedics, Inc. | MBH |
| Apr 1, 2011 | K110542 | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD Consensus Orthopedics, Inc. | LPH |
| Jan 26, 2011 | K102927 | CONSENSUS KNEE SYSTEM Consensus Orthopedics, Inc. | MBH |
| Dec 2, 2010 | K102399 | CONSENSUS TAPERSET HIP SYSTEM Consensus Orthopedics, Inc. | LPH |
| Oct 6, 2010 | K100933 | CONSENSUS CS2 PLUS ACETABULAR INSERT Consensus Orthopedics, Inc. | LPH |
| Jun 24, 2010 | K100542 | CONSENSUS REVISION KNEE SYSTEM Consensus Orthopedics, Inc. | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||