Consensus Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Consensus Orthopedics, Inc.” (first 2010, latest 2017), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 75 |
| 2013 | 1 | 280 |
| 2014 | 2 | 114 |
| 2015 | 1 | 65 |
| 2016 | 1 | 299 |
| 2017 | 2 | 256 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Consensus Orthopedics, Inc. took a median 256 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 | 5 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 1 | 1 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (17)
Most recent Consensus Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170344 | Tahoe Uni Knee System | HSX | 2017-10-05 | 244 |
| K163167 | CKS Plus Knee System | JWH | 2017-08-09 | 268 |
| K160515 | PS2 Knee System | JWH | 2016-12-19 | 299 |
| K143725 | Consensus Knee System Modular Tibial Baseplate | JWH | 2015-03-04 | 65 |
| K133919 | CONSENSUS VITALITE TIBIAL INSERT | JWH | 2014-07-14 | 203 |
| K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | LPH | 2014-05-19 | 26 |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | OQG | 2013-12-17 | 280 |
| K122512 | CS2 HIP SYSTEM | LPH | 2012-11-05 | 80 |
| K120595 | UNISYN PLUS HIP STEM | LWJ | 2012-10-12 | 227 |
| K121935 | TAPERSET HIP SMALL STEMS | LPH | 2012-09-10 | 70 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Consensus Orthopedics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Consensus Orthopedics, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Consensus Orthopedics, Inc.” (first 2010, latest 2017), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Consensus Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Consensus Orthopedics, Inc. is 114 days.
Which FDA product codes appear under Consensus Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 17 Consensus Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Consensus Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.