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

Orthomedics — Predicate Candidate Screening

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

27 daysmedian FDA review time

36 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K832740	FEMORAL FRACTURE ORTHOSIS	Orthomedics	1983-09-20	36
K832741	JASON CERVICAL ORTHOSIS	Orthomedics	1983-09-20	36
K832742	EXTENSION CONTROL KNEE ORTHOSIS	Orthomedics	1983-09-20	36
K811456	ORTHO-FRAC KIT	Orthomedics	1981-06-12	21
K811297	CERVICAL SUPPORT	Orthomedics	1981-05-27	16
K811298	EXECUTIVE COLLAR	Orthomedics	1981-05-27	16
K810555	SCOLIOSIS ORTHOTIC SYSTEM	Orthomedics	1981-03-13	11
K810554	LUMBAR FLEXION BRACE	Orthomedics	1981-03-13	11
K810557	HIP ABDUCTION SPLINT	Orthomedics	1981-03-13	11
K810556	SPINAL EXTENSION BRACE	Orthomedics	1981-03-13	11
K802910	PLASTIC FRACTURE CAST BRACE KNEE JOINT	Orthomedics	1980-12-22	35
K803033	CRUSADER HYPEREXTENSION BRACE	Orthomedics	1980-12-22	21
K802908	ULNAR FRACTURE BRACE	Orthomedics	1980-12-17	30
K802909	HUMERAL FRACTURE BRACE	Orthomedics	1980-12-17	30
K802911	A/K SOCKET	Orthomedics	1980-12-17	30
K802871	TIBIAL FRACTURE BRACE	Orthomedics	1980-12-11	27

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