Encore Orthopedics, Inc.: FDA clearances and approvals
Encore Orthopedics, Inc. has 85 FDA 510(k) clearances (first 1993, latest 2004), across 29 product codes in 2 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 16 | 16 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 13 | 13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 11 | 11 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
Plus 19 more product codes.
Review panels
Most recent Encore Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | MBH | 2004-07-06 | 293 |
| K020114 | 3D KNEE | JWH | 2002-07-12 | 182 |
| K020741 | UNICONDYLAR KNEE | HRY | 2002-06-04 | 90 |
| K020236 | MODIFICATION TO PASS SPINAL SYSTEM | KWP | 2002-02-14 | 22 |
| K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP | LPH | 2002-02-11 | 25 |
| K013490 | CEMENTED CALCAR HIP SYSTEM | LPH | 2002-01-17 | 87 |
| K013442 | PASS SPINAL SYSTEM | KWP | 2002-01-15 | 90 |
| K003324 | PLASMA SPRAYED SHOULDER | KWS | 2001-12-06 | 408 |
| K013431 | PASS SPINAL SYSTEM | MNI | 2001-11-15 | 30 |
| K013191 | PASS SPINAL SYSTEM | MNI | 2001-10-24 | 30 |
75 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Encore Orthopedics, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Encore Orthopedics, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Encore Orthopedics, Inc. have?
Encore Orthopedics, Inc. has 85 FDA 510(k) clearances (first 1993, latest 2004), across 29 product codes in 2 review panels.
How long does FDA take to clear Encore Orthopedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Encore Orthopedics, Inc.'s cleared 510(k)s is 90 days.
What devices does Encore Orthopedics, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 16); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 13); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 11).
Has Encore Orthopedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Encore Orthopedics, Inc. Related entities may recall under other names.
Next steps
- See all 85 Encore Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Encore Orthopedics, 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.