# K970751: Heidelberg External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Apr 16, 1997 after 44 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: 1 generation back to K802814 (1980). 3 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953397: Hex-Fix Field Fixator, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K802814: Orthofix Axialexternal Fixation Sys., Cintor Orthopaedic Div. (1980) Summary page 1.
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 1.

## Most influential descendants
- K090926: Smith & Nephew Rail System (2009), 10 descendants of its own
- 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
- K200518: Pitkar External Fixation System - Rail Mechanism (2020), 2 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own

## Indications for use
Indications for the Heidelberg Fixator include: fracture fixation (open and closed), pseudoarthrosis or nonunion of long bones; limb lengthening, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Source page: https://510kreport.com/device/K970751
Methodology: https://510kreport.com/methodology