# K253291: Excelsior System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ocean Global
- Decided: Jan 20, 2026 after 113 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: 15 generations back to K962616 (1996). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232838: Monkey RingsTM External Fixation System, Paragon 28, Inc. (2023) Summary page 5.
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation, Smith & Nephew (2020) Summary page 5.
- K202833: Sequel External Fixation Device, Sequel Medical, Inc. (2021) Summary page 5.

## Indications for use
The Excelsior External Fixation System is indicated for adult and pediatric (greater than 2 through 21 years of age) patients for the treatment and fixation of: * Open and closed fractures * 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, infected union, non-union, or malunion of long bones * Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction * Correction of bony or soft tissue deformity (e.g. orthoplastic surgery) * Correction of segmental bony or soft tissue defects * Joint arthrodesis * Management of comminuted intra-articular fractures * Bone transport The Excelsior External Fixation System is indicated in adults for: * Osteotomy * Revision procedure where other treatments or devices have been unsuccessful * Bone reconstruction procedures * Fusions and replantations of the foot * Charcot foot reconstruction * Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle * Lisfranc dislocations * Ankle distraction (arthrodiastasis) * Septic fusion The Excelsior Translation Device is not intended for weight bearing applications. Patients must remain non weight bearing on the Excelsior External Fixation frame when the Excelsior Translation Device is used for transport applications.

Source page: https://510kreport.com/device/K253291
Methodology: https://510kreport.com/methodology