Techmedica, Inc.: FDA clearances and approvals
Techmedica, Inc. has 31 FDA 510(k) clearances (first 1982, latest 1994), across 21 product codes in 3 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 | 5 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 | 1 |
| EZX | Mesh, Surgical, Metal | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 11 more product codes.
Review panels
- Orthopedic (26)
- General and Plastic Surgery (3)
- Dental (2)
Most recent Techmedica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | HRY | 1994-10-11 | 426 |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | MEH | 1994-09-01 | 493 |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | LZO | 1994-03-29 | 347 |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | KWY | 1994-02-01 | 406 |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | KWY | 1993-09-28 | 336 |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | LZO | 1993-07-27 | 363 |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | HWC | 1993-04-06 | 133 |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | JDI | 1993-02-23 | 718 |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | JDL | 1993-02-05 | 114 |
| K920080 | CONTINUUM KNEE SYSTEM | JWH | 1992-09-01 | 237 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Techmedica, 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.
Frequently asked questions
How many FDA 510(k) clearances does Techmedica, Inc. have?
Techmedica, Inc. has 31 FDA 510(k) clearances (first 1982, latest 1994), across 21 product codes in 3 review panels.
How long does FDA take to clear Techmedica, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Techmedica, Inc.'s cleared 510(k)s is 90 days.
What devices does Techmedica, Inc. make?
Its most frequent FDA product codes are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 5); HRS (Plate, Fixation, Bone, 3); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 2).
Has Techmedica, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Techmedica, Inc. Related entities may recall under other names.
Next steps
- See all 31 Techmedica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Techmedica, 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.