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

Stryker Trauma AG · Predicate Candidate Screening

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

57 daysmedian FDA review time

135 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172210	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker Trauma AG	2017-10-02	70	0
K153154	Asnis JFX System	Stryker Trauma AG	2015-12-28	56	0
K151178	VariAx 2 Wrist Fusion System	Stryker Trauma AG	2015-06-24	51	0
K143138	AxSOS 3 Ti Locking Plate System	Stryker Trauma AG	2014-12-22	49	0
K140961	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM	Stryker Trauma AG	2014-11-10	209	0
K141992	VARIAX 2 SYSTEM	Stryker Trauma AG	2014-08-07	16	0
K141677	VARIAX ELBOW PLATING SYSTEM	Stryker Trauma AG	2014-07-22	29	0
K141121	AXSOS 3 TI LOCKING PLATE SYSTEM	Stryker Trauma AG	2014-06-20	51	0
K141204	VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM	Stryker Trauma AG	2014-06-20	42	0
K140565	VARIAX 2 COMPRESSION PLATING SYSTEM	Stryker Trauma AG	2014-05-29	85	0
K140769	VARIAX 2 SYSTEM	Stryker Trauma AG	2014-04-17	21	0
K140376	VARIAX 2 SYSTEM	Stryker Trauma AG	2014-04-03	48	0
K140259	VARIAX CLAVICLE HOOK PLATE	Stryker Trauma AG	2014-04-01	57	0
K133451	FIXOS SCREW SYSTEM	Stryker Trauma AG	2014-02-28	108	0
K133440	AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION	Stryker Trauma AG	2013-12-18	36	0
K132502	VARIAX 2 SYSTEM	Stryker Trauma AG	2013-10-23	75	0
K131365	T2 TIBIAL NAILING SYSTEM	Stryker Trauma AG	2013-10-10	150	2
K130907	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM	Stryker Trauma AG	2013-06-10	70	0
K131132	PELVIS II IMPLANT SYSTEM	Stryker Trauma AG	2013-05-31	38	0
K130334	HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)	Stryker Trauma AG	2013-05-03	81	0
K123964	AXSOS 3 TI LOCKING PLATE SYSTEM	Stryker Trauma AG	2013-03-28	92	0
K130009	VARIAX 2 COMPRESSION PLATING SYSTEM	Stryker Trauma AG	2013-03-22	79	1
K123403	AXSOS PROXIMAL LATERAL TIBIA LONG PLATES	Stryker Trauma AG	2013-03-20	135	0
K130116	SUPERIOR LATERAL VARIAX CLAVICLE PLATE	Stryker Trauma AG	2013-03-05	48	0
K123401	GAMMA3 AND T2 RECON TARGETING DEVICES	Stryker Trauma AG	2013-01-23	79	1

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