Conformis, Inc.: FDA clearances and approvals
Conformis, Inc. has 60 FDA 510(k) clearances (first 2005, latest 2023), across 8 product codes in 2 review panels. Median 510(k) review time: 78 days. Since 2017 its median was 57 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 37 product recalls by a recalling firm named Conformis, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 78 |
| 2013 | 4 | 81 |
| 2014 | 6 | 99 |
| 2015 | 1 | 30 |
| 2016 | 5 | 61 |
| 2017 | 2 | 266 |
| 2018 | 1 | 40 |
| 2019 | 3 | 142 |
| 2020 | 4 | 43 |
| 2021 | 6 | 54 |
| 2022 | 3 | 71 |
| 2023 | 6 | 29 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Conformis, Inc.'s cleared 510(k)s took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 40 | 40 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 8 | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 4 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| OOG | Knee Arthroplasty Implantation System | 1 | 1 |
Review panels
- Orthopedic (59)
- General Hospital (1)
Most recent Conformis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | MBH | 2023-09-08 | 28 |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | MBH | 2023-07-21 | 266 |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | JWH | 2023-07-17 | 111 |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | JWH | 2023-05-26 | 28 |
| K231178 | ACTERA hip system | MEH | 2023-05-23 | 27 |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | JWH | 2023-04-27 | 30 |
| K221104 | Actera hip system | MEH | 2022-08-04 | 112 |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | 2022-07-26 | 71 |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | 2022-05-10 | 29 |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | JWH | 2021-11-10 | 26 |
50 earlier clearances. See the full list in Caduvo.
Recalls
37 product recalls in 22 recall events; 5 initiated in the last five years. Most recent: 2025-03-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Conformis, Inc. have?
Conformis, Inc. has 60 FDA 510(k) clearances (first 2005, latest 2023), across 8 product codes in 2 review panels.
How long does FDA take to clear Conformis, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Conformis, Inc.'s cleared 510(k)s is 78 days. Since 2017: 57 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Conformis, Inc. make?
Its most frequent FDA product codes are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 40); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 8); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 4).
Has Conformis, Inc. had device recalls?
openFDA lists 37 product recalls in 22 recall events by a recalling firm whose name matches Conformis, Inc; the most recent began 2025-03-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 60 Conformis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Conformis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.