510(k) Report

FDA applicant

A & E Medical Corporation

Farmingdale, NJ4 decisions2018–20205 recalls

FDA records 4 decisions for A & E Medical Corporation (Farmingdale, NJ) from 2018 to 2020: 4 510(k) clearances. All are in product code JDQ (Cerclage, Fixation). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 of them its own earlier devices. 5 recalls are 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 A & E Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 32020: 1
2018high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

5in 2019

2019: 5
2018high 5 (2019) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — A & E Medical Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • JDQCerclage, Fixation4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 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.

  • K180582Sternal Cable SystemA & E Medical Corporation · 20181cites it
  • K173579Thorecon™ Fixation SystemA & E Medical Corporation · 20181cites it

What has FDA decided for it lately?

  • K193479Sternal Cable SystemA & E Medical Corporation · 2020
  • K181607Thorecon Rigid Fixation SystemA & E Medical Corporation · 20185 recalls
  • K180582Sternal Cable SystemA & E Medical Corporation · 2018
  • K173579Thorecon™ Fixation SystemA & E Medical Corporation · 2018

All 4 as A & E Medical Corporation →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K181607A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation…Sep 10, 2019Class II
  • K181607A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or…Sep 10, 2019Class II
  • K181607A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or…Sep 10, 2019Class II
  • K181607A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation…Sep 10, 2019Class II
  • K181607A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or…Sep 10, 2019Class II