Protek, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Protek, Inc.” (first 1985, latest 1989), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 4 | 4 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 2 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| KWM | Prosthesis, Wrist, Semi-Constrained | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (24)
Most recent Protek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893785 | ARC-2F ACETABULAR CUP | LWJ | 1989-08-09 | 79 |
| K893959 | P.S.A. FEMORAL HIP PROSTHESIS | KWY | 1989-07-25 | 54 |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | LZY | 1989-07-19 | 112 |
| K883794 | RESUBMITTED CLW ACETABULAR CUP W/SULMESH | LWJ | 1989-05-26 | 261 |
| K884952 | VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC | LZO | 1989-05-10 | 162 |
| K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. | KWL | 1989-02-27 | 97 |
| K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. | JDI | 1989-02-08 | 33 |
| K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI | KWL | 1989-02-08 | 85 |
| K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS | JDI | 1988-12-29 | 37 |
| K882671 | SAMUELSON SCREWLOC CUP | KWA | 1988-10-20 | 114 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Protek, Inc..
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.
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.
- Protek Medical Products, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Protek, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Protek, Inc.” (first 1985, latest 1989), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Protek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Protek, Inc. is 85 days.
Which FDA product codes appear under Protek, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7); KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 4); KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 3).
Next steps
- See all 25 Protek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Protek, Inc.'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.