Biopro, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Biopro, Inc.” (first 1987, latest 2017), across 20 product codes in 2 review panels. Median 510(k) review time under this name: 113 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 | 1 | 117 |
| 2013 | 2 | 102 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 264 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biopro, Inc. took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 2 |
Plus 10 more product codes.
Review panels
- Orthopedic (39)
- General Hospital (2)
Most recent Biopro, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail System | HSB | 2017-09-14 | 266 |
| K162674 | BioPro Foot Plating Systems | HRS | 2017-06-16 | 263 |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | HTN | 2013-10-24 | 73 |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | JDW | 2013-06-18 | 131 |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | KWD | 2012-10-30 | 117 |
| K100761 | BIOPRO POLAR HEAD | KWY | 2010-12-03 | 261 |
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW | HWC | 2010-06-03 | 51 |
| K090208 | BIOPRO FEMORAL HEADS | JDI | 2009-05-22 | 114 |
| K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | HTY | 2009-03-18 | 113 |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | KWY | 2008-12-15 | 90 |
31 earlier clearances. See the full list in Caduvo.
Recalls
39 product recalls in 4 recall events; 16 initiated in the last five years. Most recent: 2025-09-09.
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.
- Biopro (M) Sdn Bhd (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biopro, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Biopro, Inc.” (first 1987, latest 2017), across 20 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 Biopro, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biopro, Inc. is 113 days.
Which FDA product codes appear under Biopro, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7); HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 3).
Next steps
- See all 41 Biopro, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Biopro, 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.