# K120871: Smith & Nephew, Inc. External Fixation System Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 7, 2012 after 77 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
Longest line of descent: 10 generations back to K962616 (1996). 64 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 71 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 1.
- K920024: Rihards Titanium Half Pin, Smith & Nephew Richards, Inc. (1992) Summary page 1.
- K953397: Hex-Fix Field Fixator, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K970751: Heidelberg External Fixator, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- K023134: Jet-X Tin Coated Half Pins, Smith & Nephew, Inc. (2002) Summary page 1.
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 1.
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 1.
- K033289: Modification to Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2004) Summary page 1.
- K042312: Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe, Smith & Nephew, Inc. (2004)
- K042436: Iiizarov Pulley System, Smith & Nephew, Inc. (2004) Summary page 1.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 1.
- K090926: Smith & Nephew Rail System, Smith & Nephew, Inc. (2009) Summary page 1.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K100069: Smith and Nephew Spatialframe V4.1 Web-Based Software. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K251128: Extremity Medical External Fixation System (2025), 0 descendants of its own

## Indications for use
The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion (not applicable for Smith & Nephew Rail System) 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-X 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 (not applicable for Smith & Nephew Rail System) 9. Infected fractures or nonunions 10. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius (not applicable for Smith & Nephew Rail System) 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 (not applicable for Smith & Nephew Rail System)

Source page: https://510kreport.com/device/K120871
Methodology: https://510kreport.com/methodology