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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

I.T.S. Implantat-Technologie-Systeme GmbH · Predicate Candidate Screening

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

63 daysmedian FDA review time
89 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093868I.T.S. LRS LOCKING RECONSTRUCTION SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2010-08-052311
K080706CONNEXX LOCKING TIBIA NAILI.T.S. Implantat-Technologie-Systeme GmbH2008-06-09890
K080184DISTAL HUMERAL PLATES WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2008-03-26611
K063672FIBULA PLATE PROLOCK WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2007-02-02531
K063166I.T.S. PELVIC RECONSTRUCTION SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2006-12-22651
K060156STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2006-03-20592
K052368OLECRANONPLATE WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2005-10-17491
K051642FR.O.H. CALCANEUS REPAIR SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2005-08-22631
K052011PILONPLATE WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2005-08-10161
K051412HUMERAL HEAD PLATE WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2005-07-11411
K050852CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH2005-06-22791
K043410EPIPHYSIS SCREWI.T.S. Implantat-Technologie-Systeme GmbH2005-02-24760
K033756VOLAR RADIUS PLATE WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH2004-02-06671

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