External Articulation

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781840 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ace Fischer External Fixation Device

  Class I

  FDA 510(k) K801594 Active Cleared 9 Sep 1980

• Trippi-Wells Dual Purpose Universal Tong

  Class II

  FDA 510(k) K810193 Active Cleared 20 Mar 1981

• Anal/Rectal Syringe

  Class I

  FDA 510(k) K761229 Active Cleared 24 Feb 1977

• Aim Supracondylar Nail

  Class II

  FDA 510(k) K934962 Active Cleared 22 Mar 1994

• Threaded Pin, Self Drilling

  Class II

  FDA 510(k) K781251 Active Cleared 31 Aug 1978

• Ace External Bone Clamp Part #S11

  Class II

  FDA 510(k) K791466 Active Cleared 16 Aug 1979

See all devices from Ace Orthopedic Manufacturing Co. →

• What is the External Articulation device intended to do in clinical use?

  The External Articulation is an orthopedic external fixation device designed to rigidly immobilize bone fractures. It provides compression, neutralization, or support during healing by using arcuate frame segments, adjustment rods, pin holders, and pins that extend through soft tissue and bone. It is intended for use in orthopedic clinical settings.

• How is the device supplied and is it ready for immediate use upon receipt?

  The device is supplied as a single-use, sterile unit by Ace Orthopedic Manufacturing Co. Because it is sterile and single-use, it is ready for immediate clinical application without the need for additional sterilization. It should be inspected for packaging integrity before use.

• Can the External Articulation be reused after a patient procedure?

  No, the External Articulation is explicitly designated as a single-use device. Reuse is not supported due to the risk of structural compromise, loss of sterility, and potential patient harm. Each unit must be discarded after a single patient application.

• What regulatory pathway was used for this device, and what does that indicate about its safety and effectiveness?

  The device was cleared through the FDA 510(k) premarket notification pathway under K781840, with a decision of 'Substantially Equivalent' to a legally marketed predicate device. This indicates that the manufacturer provided evidence demonstrating that the device is as safe and effective as an existing, cleared device for the same intended use.

• What storage conditions should be followed before the device is used?

  The device data does not specify particular storage conditions such as temperature or humidity limits. However, as a sterile, single-use orthopedic device, it should be stored in a dry, clean environment, protected from moisture, extreme temperatures, and physical damage until the time of use. The packaging should remain sealed and intact.