# K060283: Transet System

- Pathway: 510(k) (Special)
- Applicant: Bonutti Research, Inc.
- Decided: Feb 22, 2006 after 19 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Multitak SS Button system: named in the summary without a submission number
- (no number) stainless steel beaded cable systems: named in the summary without a submission number
- (no number) Steinmann pins: named in the summary without a submission number

## Indications for use
The TranSetTM System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site: * Up to USP Size No. 2 Suture, * Up to USP Size No. 2 High Tensile Suture, * Metallic Cable, and * Metallic Wire.

Source page: https://510kreport.com/device/K060283
Methodology: https://510kreport.com/methodology