# K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories]

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 18, 2000 after 72 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
127 later devices descend from it; 19 cite it directly.
0 of 128 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 its predicate without a number.
- (no number) Hex-Fix® Field Fixator — Smith & Nephew: named in the summary without a submission number
- (no number) Richards Colles Fracture Frame — Smith & Nephew: named in the summary without a submission number
- (no number) Simple Small External Fixator — Synthes: named in the summary without a submission number
- (no number) Compass® Universal Hinge — Smith & Nephew: named in the summary without a submission number
- (no number) Richards External Fixation System — Smith & Nephew: named in the summary without a submission number
- (no number) Taylor Spatial Frame External Fixation System - Smith & Nephew: named in the summary without a submission number

## Most influential descendants
- K093047: Smith & Nephew Circular Fixation System (2010), 51 descendants of its own
- K070555: Orthopro Steinman Pins and Kirschner Wires (2007), 37 descendants of its own
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K113006: I-Fuse Hammer Toe Systems (2012), 27 descendants of its own
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own

## Recalls of this device
- Apr 13, 2012 · Not classified · Z-1762-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1761-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1747-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1752-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1757-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1760-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1748-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1754-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1759-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1753-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1763-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1756-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1750-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1755-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1758-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1751-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1765-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1749-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Jan 23, 2009 · Not classified · Z-2027-2009: Hinge failure: The product is cracking or breaking during use.

## Indications for use
Post-traumatic joint contracture which has resulted in loss of range of motion. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction. Open and closed fracture fixation. Pseudoarthrosis of long bones. Limb lengthening by epiphyseal or metaphyseal distraction. Correction of bony or soft tissue deformities. Correction of segmental bony or soft tissue defects. Joint arthrodesis. Infected fractures or nonunions. Management of comminuted intra-articular fractures of the distal radius.

Source page: https://510kreport.com/device/K994143
Methodology: https://510kreport.com/methodology