# K163368: Fitbone Taa

- Pathway: 510(k) (Traditional)
- Applicant: Wittenstein Intens GmbH
- Decided: Jan 26, 2017 after 57 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: 7 generations back to K831576 (1983). 9 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131677: Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2013) Summary page 4.
- K131490: Ellipse Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2014) Summary page 4.

## Most influential descendants
- K203399: Fitbone (R) Taa (2021), 9 descendants of its own
- K220234: Precice Intramedullary Limb Lengthening System (2023), 3 descendants of its own
- K233867: Fitbone Trochanteric (2024), 2 descendants of its own
- K232169: FITBONE® Transport and Lengthening System (2024), 2 descendants of its own
- K232267: Precice Max System (2023), 1 descendant of its own

## Indications for use
The WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended for limb lengthening of the femur and tibia.

Source page: https://510kreport.com/device/K163368
Methodology: https://510kreport.com/methodology