Orthopaedic Biosystems, Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Orthopaedic Biosystems, Ltd.” (first 1991, latest 2000), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Orthopaedic Biosystems, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | JDR | 2000-04-03 | 21 |
| K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | JDR | 1999-03-04 | 189 |
| K983169 | POLYMER THREADED ANCHOR | MBI | 1998-12-16 | 97 |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | JDI | 1998-11-20 | 88 |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | MBI | 1998-02-06 | 228 |
| K963420 | CANCELLOUS SCREW WASHER | HTN | 1996-11-15 | 77 |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | LXT | 1996-11-13 | 75 |
| K963433 | THREADED FIXATION PIN | JDW | 1996-11-06 | 68 |
| K962779 | COMPRESSION SCREW | HWC | 1996-08-23 | 37 |
| K951451 | PEBA ANCHOR (MULTIPLE SIZES) | MBI | 1995-10-31 | 216 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthopaedic Biosystems, Ltd..
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.
- Orthopaedic Implant Company (10 510(k)s)
- Orthopaedic Innovations, Inc. (8 510(k)s)
- Orthopaedic Device Corp. (4 510(k)s)
- Orthopaedic Designs, Inc. (2 510(k)s)
- Orthopaedic Device Research Center (1 510(k)s)
- Orthopaedic Devices , Ltd. (1 510(k)s)
- Orthopaedic Medical Group, Inc. (1 510(k)s)
- Orthopaedic Resources Corp. (1 510(k)s)
- Orthopaedic & Spine Development (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthopaedic Biosystems, Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Orthopaedic Biosystems, Ltd.” (first 1991, latest 2000), across 8 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 Orthopaedic Biosystems, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthopaedic Biosystems, Ltd. is 92 days.
Which FDA product codes appear under Orthopaedic Biosystems, Ltd.?
The most frequent FDA product codes under this applicant name are JDR (Staple, Fixation, Bone, 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); HWC (Screw, Fixation, Bone, 2).
Next steps
- See all 14 Orthopaedic Biosystems, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JDR, Orthopaedic Biosystems, Ltd.'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.