Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Osteo Systems, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
498 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935383 | FEMROD AND FEMROD RECON INSERT | Applied Osteo Systems, Inc. | 1995-03-21 | 498 | 0 |
| K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION | Applied Osteo Systems, Inc. | 1995-01-27 | 528 | 0 |
| K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP | Applied Osteo Systems, Inc. | 1994-11-28 | 75 | 0 |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | Applied Osteo Systems, Inc. | 1994-10-03 | 210 | 1 |
| K943160 | INTERFERENCE SCREW | Applied Osteo Systems, Inc. | 1994-09-30 | 91 | 0 |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Applied Osteo Systems, Inc. | 1994-02-22 | 329 | 0 |
| K934148 | TRUE/FLEX CLAVICLE RODS | Applied Osteo Systems, Inc. | 1994-02-22 | 181 | 0 |
| K932853 | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS | Applied Osteo Systems, Inc. | 1994-02-22 | 257 | 0 |
| K926465 | FEMORAL INTRAMEDULLARY RODS | Applied Osteo Systems, Inc. | 1993-08-25 | 244 | 0 |
| K924656 | TRUE/ FLEX FIBULA RODS | Applied Osteo Systems, Inc. | 1992-11-24 | 70 | 0 |
| K924657 | TRUE/FLEX METATARSAL RODS | Applied Osteo Systems, Inc. | 1992-11-24 | 70 | 0 |
| K920598 | TRUE/FLEX HUMERUS CAP | Applied Osteo Systems, Inc. | 1992-04-28 | 77 | 0 |
| K913949 | TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS | Applied Osteo Systems, Inc. | 1992-01-17 | 130 | 0 |
| K912710 | TRUE/FLEX TIBIAL RODS WITH CAP | Applied Osteo Systems, Inc. | 1991-10-15 | 118 | 0 |
| K902264 | TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY | Applied Osteo Systems, Inc. | 1990-07-12 | 52 | 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