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

Theken Surgical,Llc · Predicate Candidate Screening

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

90 daysmedian FDA review time

232 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050058	THEKEN REVEAL VBR SYSTEM	Theken Surgical,Llc	2005-05-17	126	0
K032064	THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM	Theken Surgical,Llc	2004-02-20	232	1
K012462	THEKEN LARGE CEMENT RESTRICTOR	Theken Surgical,Llc	2001-10-29	89	0
K012278	THEKEN SMALL CEMENT RESTRICTOR	Theken Surgical,Llc	2001-10-17	90	0
K010466	TETHER ACFS	Theken Surgical,Llc	2001-05-16	89	0
K983622	BODYFORM THORACO-LUMBAR FIXATION SYSTEM	Theken Surgical,Llc	1998-12-30	76	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