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

Howmedica Osteonics · Predicate Candidate Screening

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

67 daysmedian FDA review time

152 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120578	ACCOLADE II HIP STEM	Howmedica Osteonics	2012-03-29	31	1
K102019	RESTORATION ACETABULAR WEDGE AUGMENTS	Howmedica Osteonics	2011-03-03	227	1
K063423	TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT	Howmedica Osteonics	2007-01-22	70	0
K033258	BONESAVE BONE VOID FILLER	Howmedica Osteonics	2004-03-09	152	0
K032855	STRYKER SPINE MAPS SYSTEM	Howmedica Osteonics	2003-12-10	89	1
K031702	REFLEX ANTERIOR CERVICAL PLATE SYSTEM	Howmedica Osteonics	2003-08-08	67	0
K031435	BONESOURCE BVF	Howmedica Osteonics	2003-08-04	90	0
K031217	GMRS PRESS FIT STEMS WITH PUREFIX HA	Howmedica Osteonics	2003-05-23	36	0
K022461	S2 FEMORAL NAIL	Howmedica Osteonics	2002-08-22	27	1
K022160	XIA SPINAL SYSTEM	Howmedica Osteonics	2002-08-01	29	0
K013772	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	Howmedica Osteonics	2001-12-03	20	0
K012172	DURACON PS LIPPED TIBIAL INSERT	Howmedica Osteonics	2001-10-10	90	2
K012027	MODIFICATION TO XIA SPINE SYSTEM	Howmedica Osteonics	2001-07-20	22	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