# K983881: Cobra External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Innovations, Inc.
- Decided: Dec 4, 1998 after 32 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 1 generation back to K960014 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960014: Practifix External Fixation System, Orthopaedic Innovations, Inc. (1996) Summary page 1.
- (no number) Synthes AO/ASIF: named in the summary without a submission number
- (no number) Howmedica Mini Hoffman External Fixation Systems: named in the summary without a submission number

## Most influential descendants
- K012078: Radiofix (2001), 0 descendants of its own

## Indications for use
The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.

Source page: https://510kreport.com/device/K983881
Methodology: https://510kreport.com/methodology