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Parcus GFS BTB

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183331

by Parcus Medical Llc

Identifiers

510(k) Number
K183331 FDA 510(k)
FDA Product Code
MBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Parcus GFS BTB is a ligament retention device classified as a fastener, fixation, nondegradable, soft tissue device under the MBI product code. It is designed for mechanical fixation of ligaments and tendons, providing secure anchoring of grafts in orthopedic procedures. Constructed from medical-grade titanium and ultra-high-molecular-weight polyethylene (UHMWPE) suture, it is intended for use in conjunction with other Parcus Medical fixation systems, such as the GFS Ultimate, GFS Mini, and GFS II.

This device is supplied sterile and is operated by surgeons in clinical or surgical settings. It is classified as a Class II medical device under FDA Special Controls and received FDA 510(k) clearance (K183331) on February 7, 2019, following a review by the Orthopedic (OR) Advisory Committee. The device is intended for single-use applications, though regulatory status and reuse instructions are not specified in the provided data.

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: Parcus GFS BTB (K183331) — FDA 510(k) | Innolitics, K183331 FDA 510 (k) - Parcus GFS BTB | Parcus Medical, LLC, Parcus GFS BTB — FDA 510 (k) K183331 | MedTracker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parcus Medical Llc
FDA Applicant
Parcus Medical, LLC

Sources (1)

  • FDA 510(k) K183331 24 fields · synced Oct 1, 2026