# K051162: Generos SB Small Bone Distraction Implant

- Pathway: 510(k) (Traditional)
- Applicant: Orthonetx, Inc.
- Decided: Jul 19, 2005 after 75 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: 5 generations back to K993886 (1999). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 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.
- K031875: Inter-OS Limb Lengthener, Inter-Os Technologies (2003) Summary page 2.
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 2.
- K992961: Lorenz Small Fragment System, Walter Lorenz Surgical, Inc. (1999) Summary page 2.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 2.

## Indications for use
The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to: * Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet; * Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet; * Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection. Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.

Source page: https://510kreport.com/device/K051162
Methodology: https://510kreport.com/methodology