510(k) Report

FDA applicant

Ace Orthopedic Manufacturing Co.

Mchenry, IL14 decisions1977–19940 recalls

FDA records 14 decisions for Ace Orthopedic Manufacturing Co. (Mchenry, IL) from 1977 to 1994: 14 510(k) clearances. Most are in product codes JEC (Component, Traction, Invasive) and HSB (Rod, Fixation, Intramedullary And Accessories). 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 Ace Orthopedic Manufacturing Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ace Orthopedic Manufacturing Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ace Orthopedic Manufacturing Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JECComponent, Traction, Invasive5decisions
  • HSBRod, Fixation, Intramedullary And Accessories2decisions
  • HAXTong, Skull For Traction1decision
  • KOASurgical Instruments, G-U, Manual (And Accessories)1decision
  • HXKHolder, Needle; Orthopedic1decision
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

Also: JDW (1), HWC (1), HRS (1).

Who builds on its devices?

Later devices cite its devices 15 times; 0 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.

  • K813554Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co. · 19825cite it
  • K920738Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co. · 19923cite it
  • K934643Ace Humeral NailAce Orthopedic Manufacturing Co. · 19942cite it
  • K926047Ace 8.0MM Cannulated Cancellous Bone ScrewAce Orthopedic Manufacturing Co. · 19932cite it
  • K810193Trippi-Wells Dual Purpose Universal TongAce Orthopedic Manufacturing Co. · 19811cites it
  • K801594Ace Fischer External Fixation DeviceAce Orthopedic Manufacturing Co. · 19801cites it

What has FDA decided for it lately?

  • K934643Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
  • K934962Aim Supracondylar NailAce Orthopedic Manufacturing Co. · 1994
  • K936045Ace Unilateral Fixator IIAce Orthopedic Manufacturing Co. · 1994
  • K926047Ace 8.0MM Cannulated Cancellous Bone ScrewAce Orthopedic Manufacturing Co. · 1993
  • K920738Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co. · 1992
  • K813554Ace/Kyle Captured Hip ScrewAce Orthopedic Manufacturing Co. · 1982
  • K810193Trippi-Wells Dual Purpose Universal TongAce Orthopedic Manufacturing Co. · 1981
  • K801594Ace Fischer External Fixation DeviceAce Orthopedic Manufacturing Co. · 1980

All 14 as Ace Orthopedic Manufacturing Co. →