Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopaedic Biosystems, Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
228 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | Orthopaedic Biosystems, Ltd. | 2000-04-03 | 21 | 0 |
| K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | 1999-03-04 | 189 | 0 |
| K983169 | POLYMER THREADED ANCHOR | Orthopaedic Biosystems, Ltd. | 1998-12-16 | 97 | 0 |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | 1998-11-20 | 88 | 0 |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | 1998-02-06 | 228 | 0 |
| K963420 | CANCELLOUS SCREW WASHER | Orthopaedic Biosystems, Ltd. | 1996-11-15 | 77 | 0 |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Orthopaedic Biosystems, Ltd. | 1996-11-13 | 75 | 0 |
| K963433 | THREADED FIXATION PIN | Orthopaedic Biosystems, Ltd. | 1996-11-06 | 68 | 0 |
| K962779 | COMPRESSION SCREW | Orthopaedic Biosystems, Ltd. | 1996-08-23 | 37 | 0 |
| K951451 | PEBA ANCHOR (MULTIPLE SIZES) | Orthopaedic Biosystems, Ltd. | 1995-10-31 | 216 | 0 |
| K942889 | SB ANCHOR | Orthopaedic Biosystems, Ltd. | 1995-08-25 | 431 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda