510(k) Report

FDA applicant

Aevumed, Inc.

Malvern, PA8 decisions2018–20260 recalls

FDA records 8 decisions for Aevumed, Inc. (Malvern, PA) from 2018 to 2026: 8 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 63 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Aevumed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2018: 12022: 12023: 12025: 22026 (partial year): 3
2018high 3 (2026) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Aevumed, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aevumed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue8decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 63 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K223878Aevumed RAPID Suture AnchorsAevumed, Inc. · 20232cite it
  • K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc. · 20182cite it
  • K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 20251cites it
  • K222363Aevumed PHANTOM™-LP Suture AnchorsAevumed, Inc. · 20221cites it
  • K253040Aevumed FASE Suture AnchorAevumed, Inc. · 20251cites it
  • K260004Aevumed PROTEKT Suture AnchorAevumed, Inc. · 20261cites it

What has FDA decided for it lately?

  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K254306Aevumed FENIX Suture AnchorAevumed, Inc. · 2026
  • K260004Aevumed PROTEKT Suture AnchorAevumed, Inc. · 2026
  • K253040Aevumed FASE Suture AnchorAevumed, Inc. · 2025
  • K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc. · 2025
  • K223878Aevumed RAPID Suture AnchorsAevumed, Inc. · 2023
  • K222363Aevumed PHANTOM™-LP Suture AnchorsAevumed, Inc. · 2022
  • K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc. · 2018

All 8 as Aevumed, Inc. →