# K043174: Stealth Fusion System, Model RR 1000

- Pathway: 510(k) (Traditional)
- Applicant: R&R Medical, Inc.
- Decided: Feb 7, 2005 after 83 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
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ilizarov External Fixation System (Smith & Nephew Richards): named in the summary without a submission number
- (no number) Orthofix® Modulsystem: named in the summary without a submission number

## Most influential descendants
- K052196: Vilex X-Fix (2005), 13 descendants of its own
- K151881: X-Fix Line Additions (2016), 7 descendants of its own
- K162033: SALVATION External Fixation System (2017), 3 descendants of its own
- K223786: Orthex External Fixation System (2023), 2 descendants of its own
- K243798: Orthex External Fixation System (2025), 1 descendant of its own

## Indications for use
The Stealth Fusion System and its accessory components are intended to be used on adults or pediatric patients as required and are intended to be used for ankle and foot joints fusion; to stabilize fractures of foot bones; (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of foot bones; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue foot defects; joint arthrodesis; and management of comminuted intra-articular foot bone fractures.

Source page: https://510kreport.com/device/K043174
Methodology: https://510kreport.com/methodology