Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Omnilife Science — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

129 daysmedian FDA review time

355 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201611	Apex Knee System	Omnilife Science	2021-04-02	291	0
K172467	OMNI ARC Anteverted Neck Hip Stem	Omnilife Science	2017-12-21	128	0
K171156	OMNI Anseris Hip Stem	Omnilife Science	2017-08-17	119	0
K163332	Apex Revision Knee System	Omnilife Science	2017-04-26	149	0
K153437	Apex Revision Knee System	Omnilife Science	2015-12-21	24	1
K133381	OMNI ARC MONOBLOCK HIP STEM	Omnilife Science	2014-03-13	129	0
K062489	APEX HCLA ACETABULAR CUP LINERS	Omnilife Science	2007-08-15	355	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