Atlas FDA

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

Truemed Group, LLC · Predicate Candidate Screening

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

329 daysmedian FDA review time
491 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEMTruemed Group, LLC2021-07-094910
K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC2019-06-102590
K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial ArzztTruemed Group, LLC2018-01-161800
K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC2017-08-033290
K133166INS HILDEN TIBIAL ARZZTTruemed Group, LLC2014-11-063850

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