# K991590: C-LEG (3C100)

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Orthopedic Industry, Inc.
- Decided: Jul 8, 1999 after 62 days
- Product code: ISW (Assembly, Knee/Shank/Ankle/Foot, External)
- Device class: 2
- Regulation: 21 CFR 890.3500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3C1: named in the summary without a submission number

## Most influential descendants
- K101859: Rel-K Artifical Limb Prosthesis (2010), 0 descendants of its own

## Recalls of this device
- Aug 10, 2006 · Not classified · Z-0363-2007: 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 wir

## Indications for use
Fitting of lower limb prosthesis Highly mobile individuals and/or individuals who need stance stability

Source page: https://510kreport.com/device/K991590
Methodology: https://510kreport.com/methodology