Minimally Invasive Bunion Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172178 FDA 510(k)
- FDA Product Code
- HRS 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 Minimally Invasive Bunion Plating System is a device designed for the surgical correction of bunions using a minimally invasive approach. It consists of a plating system intended to stabilize the first metatarsal and phalangeal bones following osteotomy.
This system is supplied non-sterile and is intended for single-use. It is used in orthopedic surgical settings and has received FDA 510(k) clearance under product code HRS, with the K-number K172178. The device is manufactured by Trilliant Surgical LLC and is not MRI conditional unless explicitly stated in the specifications.
Frequently asked questions
What is the Minimally Invasive Bunion Plating System used for?
It is designed for the surgical correction of bunions using a minimally invasive approach, specifically to stabilize the first metatarsal and phalangeal bones following osteotomy.
How is the Minimally Invasive Bunion Plating System supplied and is it reusable?
The system is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after a surgical procedure.
What regulatory pathway was used for the Minimally Invasive Bunion Plating System?
It received FDA 510(k) clearance under product code HRS with K-number K172178, indicating it was found substantially equivalent to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172178 | Class II | Active |
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Manufacturer
- Manufacturer
- Trilliant Surgical LLC
- FDA Applicant
- Trilliant Surgical, Ltd.
Sources (1)
- FDA 510(k) K172178 24 fields · synced Sep 23, 2026