Atlas FDA

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

Responsive Arthroscopy, LLC — Predicate Candidate Screening

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

37 daysmedian FDA review time
267 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC2025-10-14250
K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC2023-10-23250
K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AResponsive Arthroscopy, LLC2023-08-252250
K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AResponsive Arthroscopy, LLC2022-10-13300
K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC2021-04-271930
K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC2020-09-23190
K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC2020-09-09370
K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC2019-03-27300
K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC2019-01-182690
K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC2019-01-032670
K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC2018-11-232630

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