# K093057: Biomet Vision Footring System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Dec 1, 2009 after 62 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: 2 generations back to K890814 (1989). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041706: Hoffmann II Foot Ring, Howmedica Osteonics Corp. (2004) Summary page 2.
- K071394: Modification to:Sbi Ringfix, Small Bone Innovations, Inc. (2007) Summary page 2.

## Most influential descendants
- K140463: Integra External Fixation System (2014), 3 descendants of its own
- K181630: Revolution External Plating System (2019), 1 descendant of its own
- K233025: Revolution External Plating System (2024), 0 descendants of its own
- K160830: Integra External Fixation System (2016), 0 descendants of its own
- K093753: Mdpo Frame System (2010), 0 descendants of its own

## Indications for use
The Biomet® Visions Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomnies, artlhrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality. Additional indications include: * Correction of deformity * Revision procedures where othcr treatments or devices have been unsuccessful * Bone reconstruction procedures * Fusions and replantations of the foot * Charcot foot reconstruction and Lisifane dislocations * Ankle distraction (arthrodiastasis)

Source page: https://510kreport.com/device/K093057
Methodology: https://510kreport.com/methodology
