# K202833: Sequel External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sequel Medical, Inc.
- Decided: Jan 19, 2021 after 116 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: 14 generations back to K962616 (1996). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190486: Pitkar External Fixation System, S.H.Pitkar Orthotools Pvt., Ltd. (2019) Summary page 5.
- K071394: Modification to:Sbi Ringfix, Small Bone Innovations, Inc. (2007) Summary page 5.
- K170650: Orthofix TrueLok Hexapod System (TL-HEX) V2.0, Orthofix Srl (2017) Summary page 5.

## Most influential descendants
- K253291: Excelsior System (2026), 0 descendants of its own

## Indications for use
The Sequel Ring Fixation System is indicated for both adults and pediatric patients for: 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

Source page: https://510kreport.com/device/K202833
Methodology: https://510kreport.com/methodology