510(k) Report

FDA applicant

Valeris Medical

Marietta, GA4 decisions2014–20201 recall

FDA records 4 decisions for Valeris Medical (Marietta, GA) from 2014 to 2020: 4 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 5 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Valeris Medical, Inc.”.

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 Valeris Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2014: 12015: 12020: 2
2014high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2014high 1 (2018) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Valeris Medical by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Valeris Medical’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 Tissue4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 20143cite it
  • K152255BoneCam Suture AnchorsValeris Medical · 20151cites it
  • K192810Apollo Suture Anchor SystemValeris Medical · 20201cites it

What has FDA decided for it lately?

  • K193108Bonecam Suture AnchorValeris Medical, Inc. · 2020
  • K192810Apollo Suture Anchor SystemValeris Medical · 2020
  • K152255BoneCam Suture AnchorsValeris Medical · 2015
  • K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 20141 recall

All 3 as Valeris Medical →The one decision as Valeris Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142230Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended…Jan 22, 2018Class II