# K110426: Dyna-Extor II

- Pathway: 510(k) (Traditional)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Nov 2, 2011 after 261 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Howmedica Mono-tube system and components: named in the summary without a submission number
- (no number) Orthofix Penning system: named in the summary without a submission number
- (no number) Orthofix Minirail system: named in the summary without a submission number
- (no number) Stryker-Howmedica Apex Pin: named in the summary without a submission number

## Indications for use
The Dyna-EXTOR(L) I1 and Dyna-EXTOR(M) 11 external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery. The Dyna-EXTOR(SM) 11 external fixation system is intended for use in upper extremity applications fdr the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities. Dyna-EXTOR(ST) 11 external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

Source page: https://510kreport.com/device/K110426
Methodology: https://510kreport.com/methodology