Atlas FDA

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

Thackray USA — Predicate Candidate Screening

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

77 daysmedian FDA review time
331 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882890WROBLEWSKI SPRING COMPRESSION WIRE SYSTEMThackray USA1988-08-08280
K871867ELITE MODULAR HIP SYSTEMThackray USA1988-04-083310
K871852COXA ACETABULAR CUPThackray USA1988-02-182820
K863554THACKRAY CRUCIATE SPARING KNEE CS-1Thackray USA1986-10-06240
K855166THACKRAY TOTAL CONDYLAR KNEESThackray USA1986-03-13770

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