# K060026: Koby Surgical Internal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Koby Surgical
- Decided: Jan 26, 2006 after 22 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
103 later devices descend from it; 4 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K120493: Mini Cannulated Headed and Headless Screw Set (2012), 39 descendants of its own
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own

## Indications for use
The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K060026
Methodology: https://510kreport.com/methodology