# K970713: Compass Universal Hinge

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Apr 3, 1997 after 35 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
No predicates in its family tree.
18 later devices descend from it; 8 cite it directly.
0 of 19 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) Ilizarov External Fixator: named in the summary without a submission number
- (no number) Dynamic Joint Distractor: named in the summary without a submission number

## Most influential descendants
- K120871: Smith & Nephew, Inc. External Fixation System Instrumentation (2012), 6 descendants of its own
- K980370: Biosymmetric Proximal Interphalangeal Joint Fixator (1998), 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
- K094043: Ligamentotaxor (2010), 3 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own

## Indications for use
The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.

Source page: https://510kreport.com/device/K970713
Methodology: https://510kreport.com/methodology