# K253613: Monkey Rings External Ring Fixation System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Dec 19, 2025 after 31 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: 11 generations back to K994143 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212895: Paragon 28 External Ring Fixation System, Paragon 28, Inc. (2021) Summary page 7.

## Indications for use
The Monkey Rings TM External Fixation System is intended to be used in adults and pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday). The Monkey Rings External Ring Fixation System is intended to treat the following patient indications in pediatric patients and adults 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 Monkey Rings External Ring 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

Source page: https://510kreport.com/device/K253613
Methodology: https://510kreport.com/methodology