Atlas FDA

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

I.T.S. GmbH · Predicate Candidate Screening

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

138 daysmedian FDA review time
520 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar I.T.S. GmbH2026-06-16850
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-241060
K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH2024-02-121380
K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH2022-08-315201
K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH2014-09-26291
K132945CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CAI.T.S. GmbH2014-03-071690
K131722I.T.S. EXTREMITY FIXATION SYSTEMSI.T.S. GmbH2013-08-07562
K130008DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATI.T.S. GmbH2013-06-251741

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