# K042436: Iiizarov Pulley System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 7, 2004 after 29 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: 1 generation back to K870961 (1987). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 2.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 2.

## Cited in the summary but kept off the family tree
- K87516: Smith & Nephew Orthopaedic Cable System. Number could not be read Summary page 2.

## Most influential descendants
- K120871: Smith & Nephew, Inc. External Fixation System Instrumentation (2012), 6 descendants of its own
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation (2020), 5 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K253202: Hoffmann LRF System (2025), 0 descendants of its own

## 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 need. These devices are modular, therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-XTh Fixator) 6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge) 7. Correction of segmental bony or soft tissue defects 8. Joint arthrodesis 9. Infected fractures or nonunions 10. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius. 11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia. The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew, The indications for the Ilizarov Pulley System are pseudoarthrosis of long bones, included as number 4 above. These indications are similar to the indications of the predicate devices. The device is intended for single use.

Source page: https://510kreport.com/device/K042436
Methodology: https://510kreport.com/methodology