# K202762: Circular Fixation with Balanced Cable Transport

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 16, 2020 after 56 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: 2 generations back to K870961 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042436: Iiizarov Pulley System, Smith & Nephew, Inc. (2004) Summary page 4.

## Indications for use
External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient’s needs. These devices are modular therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications: 1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudoarthrosis of long bones 4. Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge) 5. Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge). 6. Joint arthrodesis (not applicable for use with COMPASS Universal Hinge) 7. Infected fractures 8. Nonunions The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew. These indications are similar to the indications of the predicate devices. The device is intended for single use.

Source page: https://510kreport.com/device/K202762
Methodology: https://510kreport.com/methodology