# K052005: R&R External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: R&R Medical, Inc.
- Decided: Sep 6, 2005 after 43 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: 1 generation back to K941048 (1994). 3 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941048: True/Lok Monolateral/Bilateral Fixator, Applied Osteo Systems, Inc. (1994) Summary page 1.
- K951357: Ebi Small External Fixator (S/E/F/), Electro-Biology, Inc. (1995) Summary page 1.
- K970290: Ebi X Fix Dynafix Mini External Fixation System, Ebi, L.P. (1997) Summary page 1.
- (no number) Small Bone External Fixation System: named in the summary without a submission number

## Most influential descendants
- K100137: Sidekick Circular Fixator System: Struts and Hinges (2010), 6 descendants of its own
- K153635: SALVATION (R) External Fixation System (2016), 4 descendants of its own
- K162033: SALVATION External Fixation System (2017), 3 descendants of its own
- K113106: Dne External Fixation System (2012), 2 descendants of its own
- K180832: SALVATION External Fixation System (2018), 1 descendant of its own

## Indications for use
The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna. The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Source page: https://510kreport.com/device/K052005
Methodology: https://510kreport.com/methodology