Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omni Life Science, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
198 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019-09-25 | 86 | 0 |
| K152919 | OMNI Skirted Heads | Omni Life Science, Inc. | 2016-03-10 | 160 | 0 |
| K131472 | APEX KNEE MODULAR TIBIA SYSTEM | Omni Life Science, Inc. | 2013-10-08 | 139 | 0 |
| K112891 | APEX REVISION KNEE SYSTEMS | Omni Life Science, Inc. | 2012-02-29 | 152 | 1 |
| K113242 | APEX ARC HIP STEM | Omni Life Science, Inc. | 2012-01-05 | 64 | 0 |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | Omni Life Science, Inc. | 2011-07-13 | 86 | 0 |
| K111193 | APEX ARC HIP STEM | Omni Life Science, Inc. | 2011-06-27 | 60 | 0 |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | Omni Life Science, Inc. | 2011-06-22 | 56 | 0 |
| K110947 | APEX K1 HIP STEM | Omni Life Science, Inc. | 2011-06-16 | 73 | 0 |
| K102578 | APEX PS KNEE SYSTEM | Omni Life Science, Inc. | 2011-03-25 | 198 | 0 |
| K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET | Omni Life Science, Inc. | 2010-09-14 | 63 | 0 |
| K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD | Omni Life Science, Inc. | 2010-06-22 | 28 | 0 |
| K090845 | APEX ARC HIP STEM | Omni Life Science, Inc. | 2010-04-07 | 376 | 2 |
| K100555 | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F | Omni Life Science, Inc. | 2010-03-29 | 28 | 0 |
| K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, | Omni Life Science, Inc. | 2010-03-05 | 66 | 6 |
| K092443 | INTERFACE ACETABULAR CUP LINERS | Omni Life Science, Inc. | 2009-10-23 | 74 | 0 |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, X | Omni Life Science, Inc. | 2009-02-18 | 175 | 23 |
| K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOL | Omni Life Science, Inc. | 2008-05-23 | 59 | 0 |
| K073150 | APEX-LNK POLY ACETABULAR CUP LINERS | Omni Life Science, Inc. | 2008-02-27 | 111 | 0 |
| K060072 | MONOBLOCK PRESS-FIT HIP STEM | Omni Life Science, Inc. | 2006-08-24 | 227 | 0 |
| K060192 | APEX KNEE SYSTEM | Omni Life Science, Inc. | 2006-06-15 | 141 | 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