Paragon 28 External Ring Fixation System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K212895 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Paragon 28 External Ring Fixation System is an external fixation device used in orthopedic surgery. It utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings to fixate or correct bone.
The system is supplied as a kit for use in surgical settings and has received FDA 510(k) clearance under K212895. It is indicated for use in hindfoot procedures and is designed to allow gradual manipulation or static placement of rings for bone fixation or correction.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: External Fixation Systems - Paragon 28, Monkey Rings™ External Fixation System - Paragon 28, Paragon 28 External Ring Fixation System (K212895) — FDA 510(k ..., K212895 FDA 510(k) - Paragon 28 External Ring Fixation System, PDF K212895 - Paragon 28 External Ring Fixation System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212895 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K212895 24 fields · synced Sep 26, 2026