Atlas FDA

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

Riverpoint Medical, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time
171 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC2026-03-111100
K253695LigaMendRiverpoint Medical, LLC2026-02-27980
K243988RootMend MRRRiverpoint Medical, LLC2025-03-20840
K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC2024-11-26960
K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC2023-10-06570
K231078All-Suture AnchorRiverpoint Medical, LLC2023-10-051710
K231278Knotless Suture AnchorRiverpoint Medical, LLC2023-08-01901
K220765HS Fiber CerclageRiverpoint Medical, LLC2023-07-264970
K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC2023-05-17270
K230212OrthoButton ALRiverpoint Medical, LLC2023-02-23280
K202242HS FiberRiverpoint Medical, LLC2020-09-10310

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