# K163653: NOVOS-NAIL Limb Lengthening System (LLS)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Oct 13, 2017 after 294 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K831576 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor), Orthodyne, Inc. (2001) Summary page 6.
- K101997: Ellipse Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2011) Summary page 6.

## Indications for use
The NOVOS-NAIL Limb Lengthening System is indicated for limb lengthening of the femur and tibia.

Source page: https://510kreport.com/device/K163653
Methodology: https://510kreport.com/methodology