Biologically Oriented Prostheses: FDA clearances and approvals
Biologically Oriented Prostheses has 9 FDA 510(k) clearances (first 1995, latest 2000), across 6 product codes in 1 review panel. 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Biologically Oriented Prostheses 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002325 | WUJIN #3 TIBIAL NAIL | JDS | 2000-10-30 | 90 |
| K992144 | BIOPRO RIMMED ACETABULAR COMPOMENT | LZO | 1999-09-22 | 90 |
| K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | KYI | 1997-02-03 | 88 |
| K962769 | HORIZON HIP SYSTEM | LPH | 1996-10-03 | 79 |
| K955916 | TOWNLEY TOTAL ELBOW SYSTEM | JDC | 1996-08-08 | 223 |
| K954768 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD | LZO | 1996-01-18 | 93 |
| K952731 | TOWNLEY ALL POLY ACETABULAR CUP | JDI | 1995-12-28 | 196 |
| K953045 | BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD | LZO | 1995-09-27 | 89 |
| K951356 | VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED | LPH | 1995-06-19 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Biologically Oriented Prostheses.
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 Biologically Oriented Prostheses have?
Biologically Oriented Prostheses has 9 FDA 510(k) clearances (first 1995, latest 2000), across 6 product codes in 1 review panel.
How long does FDA take to clear Biologically Oriented Prostheses's 510(k)s?
The median time from FDA receipt to decision across Biologically Oriented Prostheses's cleared 510(k)s is 90 days.
What devices does Biologically Oriented Prostheses make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 3); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2); JDC (Prosthesis, Elbow, Constrained, Cemented, 1).
Has Biologically Oriented Prostheses had device recalls?
openFDA lists no recalls under a recalling firm name matching Biologically Oriented Prostheses. Related entities may recall under other names.
Next steps
- See all 9 Biologically Oriented Prostheses clearances with predicates and recalls
- Run predicate analysis for product code LZO, Biologically Oriented Prostheses'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.