Cleared Special

K050227 - THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER

K050227 is an FDA 510(k) clearance for THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 29-day FDA review.

K050227 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
29d
Days
Class 2
Risk

K050227 is an FDA 510(k) clearance for the THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on March 2, 2005 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K050227

510(k) Number K050227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2005
Decision Date March 02, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K050227.
ANSPACH KNOTLESS ANCHOR
K052572 · The Anspach Effort, Inc. · Dec 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · Axya Medical, Inc. · Oct 2005
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
K051069 · Arthrotek, Inc. · Jun 2005
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · Opus Medical, Inc. · Nov 2004
TI - SCREW ANCHOR SP
K042460 · Arthrotek, Inc. · Oct 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · Linvatec Corp. · Jul 2004