# K212895: Paragon 28 External Ring Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Nov 8, 2021 after 59 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: 10 generations back to K994143 (2000). 14 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203568: Hoffmann LRF System, Stryker GmbH (2021) Summary page 5.

## Most influential descendants
- K232838: Monkey RingsTM External Fixation System (2023), 3 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K253613: Monkey Rings External Ring Fixation System (2025), 0 descendants of its own
- K251128: Extremity Medical External Fixation System (2025), 0 descendants of its own

## Indications for use
The Paragon 28 External Ring 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 Paragon 28 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/K212895
Methodology: https://510kreport.com/methodology