# K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Dec 8, 2020 after 211 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: 11 generations back to K962616 (1996). 66 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090926: Smith & Nephew Rail System, Smith & Nephew, Inc. (2009) Summary page 11.
- K120871: Smith & Nephew, Inc. External Fixation System Instrumentation, Smith & Nephew, Inc. (2012) Summary page 11.
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 11.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 11.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 11.
- K023134: Jet-X Tin Coated Half Pins, Smith & Nephew, Inc. (2002) Summary page 11.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 11.
- K042312: Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe, Smith & Nephew, Inc. (2004) Summary page 11.
- K042436: Iiizarov Pulley System, Smith & Nephew, Inc. (2004) Summary page 11.
- K920024: Rihards Titanium Half Pin, Smith & Nephew Richards, Inc. (1992) Summary page 11.
- K953397: Hex-Fix Field Fixator, Smith & Nephew Richards, Inc. (1995) Summary page 11.
- K970751: Heidelberg External Fixator, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 11.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 11.
- K130479: Ilizarov Drill Tip Wires, Smith & Nephew, Inc. (2013) Summary page 11.

## Most influential descendants
- 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
- K241769: Response Ortho Metaphyseal Hinge Fixator System (2024), 0 descendants of its own

## Indications for use
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. Pseudarthrosis 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 1. Open and closed fractures fixation 2. Bony or soft tissue deformities 3. Infected fractures 4. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius 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. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Infected fractures 7. Nonunions 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. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

Source page: https://510kreport.com/device/K201253
Methodology: https://510kreport.com/methodology