Implex Corp.: FDA clearances and approvals
Implex Corp. has 65 FDA 510(k) clearances (first 1993, latest 2005), across 18 product codes in 2 review panels. Median 510(k) review time: 81 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 17 | 17 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 10 | 10 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 10 | 10 |
| MQP | Spinal Vertebral Body Replacement Device | 8 | 8 |
| EZX | Mesh, Surgical, Metal | 3 | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| 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 |
| FTM | Mesh, Surgical | 1 | 1 |
Plus 8 more product codes.
Review panels
Most recent Implex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT | MQP | 2005-09-23 | 64 |
| K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 | MQP | 2005-06-17 | 38 |
| K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | MBH | 2004-12-21 | 300 |
| K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ | JWH | 2004-09-30 | 204 |
| K040756 | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX | FTM | 2004-07-14 | 112 |
| K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | JWH | 2004-01-08 | 197 |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | JDK | 2003-11-19 | 27 |
| K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT | MQP | 2003-10-31 | 77 |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | EZX | 2003-10-02 | 64 |
| K031449 | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION | KWS | 2003-09-23 | 139 |
55 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Implex Corp..
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 Implex Corp. have?
Implex Corp. has 65 FDA 510(k) clearances (first 1993, latest 2005), across 18 product codes in 2 review panels.
How long does FDA take to clear Implex Corp.'s 510(k)s?
The median time from FDA receipt to decision across Implex Corp.'s cleared 510(k)s is 81 days.
What devices does Implex Corp. make?
Its most frequent FDA product codes are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 17); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 10); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 10).
Has Implex Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Implex Corp. Related entities may recall under other names.
Next steps
- See all 65 Implex Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Implex Corp.'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.