# K071394: Modification to:Sbi Ringfix

- Pathway: 510(k) (Special)
- Applicant: Small Bone Innovations, Inc.
- Decided: Jun 29, 2007 after 39 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890814 (1989). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890814: Danek Ring Fixator (DRF), Danek Medical, Inc. (1989) Summary page 1.

## Most influential descendants
- K093057: Biomet Vision Footring System (2009), 5 descendants of its own
- K140463: Integra External Fixation System (2014), 3 descendants of its own
- K202833: Sequel External Fixation Device (2021), 1 descendant of its own
- K181630: Revolution External Plating System (2019), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own

## Recalls of this device
- Apr 7, 2014 · Class II · Z-1720-2014: Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter

## Indications for use
The RingFIXTM System is intended for: 1. fracture fixation (open and closed) 2. pseudarthrosis or nonunions of long bones 3. limb lengthening by epiphyseal or metaphyseal distraction 4. correction of bony or soft tissue deformities 5. correction of segmental bony or soft tissue defects

Source page: https://510kreport.com/device/K071394
Methodology: https://510kreport.com/methodology