# K052498: Fragment Specific Fixator

- Pathway: 510(k) (Traditional)
- Applicant: David J. Slutsky MD
- Decided: Oct 17, 2005 after 35 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 K942906 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series, Zimmer, Inc. (2004) Summary page 1.
- K050048: Hoffman II Micro External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 1.

## Indications for use
The Fragment Specific fixator is intended for use in adult male and females from skeletal maturity to the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.

Source page: https://510kreport.com/device/K052498
Methodology: https://510kreport.com/methodology