Atlas FDA

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

Osteoremedies, LLC — Predicate Candidate Screening

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

55 daysmedian FDA review time
267 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLC2026-07-24180
K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2025-12-23320
K250760SPECTRUM GV Bone CementOsteoremedies, LLC2025-04-02200
K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial CompoOsteoremedies, LLC2024-10-02540
K231556SPECTRUM® GV Bone CementOsteoremedies, LLC2023-12-202040
K223650REMEDY Stemmed Knee SpacerOsteoremedies, LLC2023-01-05300
K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2020-01-10770
K191981REMEDY Acetabular CupOsteoremedies, LLC2019-08-23300
K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC2019-07-252670
K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC2018-08-293410
K173967Remedy Acetabular CupOsteoremedies, LLC2018-02-22550
K152267Remedy® Shoulder SpacerOsteoremedies, LLC2015-12-151260

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