# Aevumed, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 8 (2018–2026): 8 510(k) clearances
- Product codes: MBI (8)
- 510(k) review time since 2016: median 90 days, against 63 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)

## Firms that cite its devices most
- ArthroTAK, LLC: 1 (https://510kreport.com/company/arthrotak)

## Its most-cited devices
- K223878: Aevumed RAPID Suture Anchors (2023), cited by 2
- K180464: AEVUMED PHANTOM Suture Anchors (2018), cited by 2
- K242895: Aevumed PHANTOM Suture Anchors (2025), cited by 1
- K222363: Aevumed PHANTOM™-LP Suture Anchors (2022), cited by 1
- K253040: Aevumed FASE Suture Anchor (2025), cited by 1
- K260004: Aevumed PROTEKT Suture Anchor (2026), cited by 1

## Recent decisions
- K253065: Aevumed SUPERCYNCH™ Button System (Sep 2, 2026)
- K254306: Aevumed FENIX Suture Anchor (Mar 4, 2026)
- K260004: Aevumed PROTEKT Suture Anchor (Jan 28, 2026)
- K253040: Aevumed FASE Suture Anchor (Oct 21, 2025)
- K242895: Aevumed PHANTOM Suture Anchors (Aug 6, 2025)
- K223878: Aevumed RAPID Suture Anchors (Mar 17, 2023)
- K222363: Aevumed PHANTOM™-LP Suture Anchors (Nov 28, 2022)
- K180464: AEVUMED PHANTOM Suture Anchors (May 31, 2018)

Source page: https://510kreport.com/company/aevumed