Encore Medical L.P.: FDA filings under this applicant name
FDA lists 81 510(k) clearances under the applicant name “Encore Medical L.P.” (first 2002, latest 2026), across 17 product codes in 2 review panels. Median 510(k) review time under this name: 93 days. Since 2017 the median was 90 days, against 102 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Enovis (DJO), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 64 |
| 2013 | 5 | 222 |
| 2014 | 5 | 108 |
| 2015 | 1 | 184 |
| 2016 | 4 | 112 |
| 2017 | 6 | 90 |
| 2018 | 2 | 90 |
| 2019 | 3 | 74 |
| 2020 | 2 | 138 |
| 2021 | 2 | 60 |
| 2022 | 2 | 191 |
| 2023 | 1 | 301 |
| 2024 | 1 | 216 |
| 2025 | 7 | 71 |
| 2026 | 1 | 154 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Encore Medical L.P. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 16 | 16 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 15 | 15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 12 | 12 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 9 | 9 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 5 | 5 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 | 3 |
Plus 7 more product codes.
Review panels
- Orthopedic (80)
- Physical Medicine (1)
Most recent Encore Medical L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252567 | AltiVate Reverse® ADLC Glenosphere | PHX | 2026-01-15 | 154 |
| K252974 | EMPOWR Knee | JWH | 2025-12-19 | 93 |
| K251833 | EMPOWR Acetabular® Liner Extension | LPH | 2025-11-12 | 149 |
| K252141 | AltiVate Reverse® Glenoid | PHX | 2025-08-05 | 28 |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | JWH | 2025-07-08 | 28 |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | JWH | 2025-07-02 | 71 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | PHX | 2025-05-16 | 30 |
| K241483 | ceramys femoral head system | LZO | 2025-02-07 | 259 |
| K233481 | AltiVate Reverse® Glenoid | PHX | 2024-05-29 | 216 |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | KWS | 2023-06-23 | 301 |
71 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Encore Medical L.P..
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.
Device clinical trials
An industry sponsor named Encore Medical L.P. is the lead sponsor of 11 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03711175: The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty (Enrolling by invitation, started 2018-09-28)
- NCT01514318: Encore Revelation Hip Stem (Completed, started 2012-02)
- NCT01274546: Long Term Foundation Knee Study (Completed, started 2010-08)
- NCT01005446: Reverse Shoulder Prosthesis Prospective Multi-Center Study (Completed, started 2009-12)
- NCT01284283: 2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (Completed, started 2009-11)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Encore Orthopedics, Inc. (85 510(k)s)
- Encore Medical, LLC (3 510(k)s)
- Encore Guards (2 510(k)s)
- Encore Medical, L.P Dba Enovis (2 510(k)s)
- Encore Products, Inc. (2 510(k)s)
- Encore, Inc. (1 510(k)s)
- Encore Medical, L.P. Dba Djo Surgical (1 510(k)s)
- Encore Medical, L.P. (Dba Enovis) (1 510(k)s)
- Encore Technology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Encore Medical L.P.?
FDA lists 81 510(k) clearances under the applicant name “Encore Medical L.P.” (first 2002, latest 2026), across 17 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Encore Medical L.P.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Encore Medical L.P. is 93 days. Since 2017: 90 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Encore Medical L.P.?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 16); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 15); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 12).
Next steps
- See all 81 Encore Medical L.P. clearances with predicates and recalls
- Run predicate analysis for product code PHX, Encore Medical L.P.'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.