C-Leg (3C100)

• • Terminated Z-0363-2007 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006 ·on shared 510(k) K991590

  A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K991590 ↗

FDA Product Code

ISW

Device Class

Class II

Regulation

21 CFR Part 890.3500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• What is the C-Leg (3C100) intended to assist with?

  The C-Leg (3C100) is a microprocessor-controlled external knee-ankle-foot orthosis (KAFO) designed to assist individuals with lower-limb mobility impairments, providing dynamic stability and support during gait cycles to enhance functional independence for users with conditions such as spinal cord injury, stroke, or other neurological impairments.

• Is the C-Leg (3C100) supplied sterile or non-sterile, and is it intended for single use or reuse?

  The C-Leg (3C100) is supplied as a reusable, non-sterile medical device, meaning it is designed for multiple uses after appropriate cleaning and maintenance, and is not provided in a sterile condition nor intended for single-use disposal.

• What regulatory pathway was used for the C-Leg (3C100), and what is its classification?

  The C-Leg (3C100) received FDA 510(k) clearance under K991590 and is regulated as a Class II medical device under regulation 890.3500, indicating it was found substantially equivalent to a predicate device through the traditional 510(k) pathway.

• In what settings is the C-Leg (3C100) intended to be used, and who is responsible for its proper use?

  The C-Leg (3C100) is intended for use in both clinical and home settings, requiring proper fitting, calibration, and maintenance by trained professionals or users who have received appropriate instruction to ensure optimal performance and safety.