Hoffmann II Compact Periarticular Clamp

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

510(k) Number

K973321 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the Hoffmann II Compact Periarticular Clamp used for?

  The Hoffmann II Compact Periarticular Clamp is used in the stabilization of open and/or unstable fractures, particularly when soft tissue injury may prevent other fracture treatments. It functions as a mechanical clamp connecting percutaneous pins to rods and couplings to form an external fixation frame.

• Is the Hoffmann II Compact Periarticular Clamp reusable or single-use?

  The Hoffmann II Compact Periarticular Clamp is a reusable device designed for multiple applications in orthopedic settings. It should be properly cleaned and stored according to the manufacturer's instructions between uses.

• What materials is the Hoffmann II Compact Periarticular Clamp made from?

  The Hoffmann II Compact Periarticular Clamp is manufactured from radiolucent plastic material, which allows for clear radiographic visualization of fractures or joints during medical procedures without interference from the device itself.

• What is the regulatory status of the Hoffmann II Compact Periarticular Clamp?

  The Hoffmann II Compact Periarticular Clamp is authorized under FDA 510(k) clearance with product code KTT and K number K973321. It received traditional clearance on November 20, 1997, and was determined to be substantially equivalent to predicate devices.