# K110965: Renovis T 710 Large External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: May 11, 2011 after 35 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 K803166 (1981). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861766: Howmedica Hoffmann Fixation Pin System, Howmedica Corp. (1986) Summary page 1.
- K011136: Apex Fixation Pins, Howmedica Osteonics Corp. (2001)
- K952730: Hoffmann II External Fixation System, Howmedica Corp. (1995) Summary page 1.
- K010344: Adjustable Large Fixator System, Synthes (Usa) (2001) Summary page 1.
- K984357: Transfx External Fixation System, Immedica, Inc. (1999) Summary page 1.

## Most influential descendants
- K213905: ONX Large External Fixation System (2022), 0 descendants of its own
- K171211: OIC External Fixation System (2017), 0 descendants of its own

## Indications for use
The Renovis T 710 Large External Fixation System is indicated for the following: *Stabilization/fixation of: o Long bone fractures in tibia and femur o Fractures of pelvis and ankle o Peri-articular and intra-articular fractures of knee and ankle *Joint arthrodesis *Non-unions and mal-unions *Osteotomies

Source page: https://510kreport.com/device/K110965
Methodology: https://510kreport.com/methodology