# K232838: Monkey RingsTM External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Oct 12, 2023 after 28 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.
3 later devices descend from it; 2 cite it directly.
0 of 19 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 5.

## Most influential descendants
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K251128: Extremity Medical External Fixation System (2025), 0 descendants of its own

## Indications for use
The Monkey RingsTM External Fixation System is indicated 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 RingsTM 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

Source page: https://510kreport.com/device/K232838
Methodology: https://510kreport.com/methodology