510(k) Report

FDA applicant

Iconn Orthopedics, LLC

Birmingham, AL5 decisions2014–20180 recalls

FDA records 5 decisions for Iconn Orthopedics, LLC (Birmingham, AL) from 2014 to 2018: 5 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 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 Iconn Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2018

2014: 12017: 12018: 3
2014high 3 (2018) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue4decisions
  • HWCScrew, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 82 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132724Iconn Answer Suture AnchorIconn Orthopedics, LLC · 20141cites it

What has FDA decided for it lately?

  • K180670ICONN Campbell Interference ScrewIconn Orthopedics, LLC · 2018
  • K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC · 2018
  • K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC · 2018
  • K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC · 2017
  • K132724Iconn Answer Suture AnchorIconn Orthopedics, LLC · 2014

All 5 as Iconn Orthopedics, LLC →