# K031875: Inter-OS Limb Lengthener

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Os Technologies
- Decided: Oct 22, 2003 after 127 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K993886 (1999). 15 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K993869: Inter-OS Bone Generator, Inter-Os Technologies, LLC (2000) Summary page 2.
- K982222: Synthes (Usa) Distal Femur Plate (DFP) System, Synthes (Usa) (1998) Summary page 2.
- K020872: Synthes 3.5 MM Broad LC-DCP Plates, Synthes (Usa) (2002) Summary page 2.
- K991941: Ebi Xfix DFS Rail System, Electro-Biology, Inc. (1999) Summary page 2.
- K000083: Ebi Xfix DFS Rail System, Ebi, L.P. (2000) Summary page 2.
- K010437: Modification to Ebi Xfix DFS Rail System, Ebi, L.P. (2001) Summary page 2.
- K021031: Ebi Xfix Rail System, Ebi, L.P. (2002)
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor), Orthodyne, Inc. (2001)

## Most influential descendants
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own
- K193617: Precice® Screws (2020), 0 descendants of its own
- K051162: Generos SB Small Bone Distraction Implant (2005), 0 descendants of its own

## Indications for use
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are: Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities. The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.

Source page: https://510kreport.com/device/K031875
Methodology: https://510kreport.com/methodology