# K101859: Rel-K Artifical Limb Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Rizzoli Ortopedica S.P.A.
- Decided: Oct 13, 2010 after 103 days
- Product code: ISY (Joint, Knee, External Limb Component)
- Device class: 1
- Regulation: 21 CFR 890.3420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991590 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991590: C-LEG (3C100), Otto Bock Orthopedic Industry, Inc. (1999) Summary page 1.

## Indications for use
REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions

Source page: https://510kreport.com/device/K101859
Methodology: https://510kreport.com/methodology