Cleared Traditional

K260106 - OsteoCoil™ GT Active Compression System

K260106 is an FDA 510(k) clearance for OsteoCoil GT Active Compression System, manufactured by Flower Orthopedics Corporation DBA Conventus Flower Orthoped. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K260106 · Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
222d
Days
Class 2
Risk

K260106 is an FDA 510(k) clearance for the OsteoCoil™ GT Active Compression System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Flower Orthopedics Corporation DBA Conventus Flower Orthoped (Horsham, US). The FDA issued a Cleared decision on August 24, 2026 after a review of 222 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Flower Orthopedics Corporation DBA Conventus Flower Orthoped devices

FDA 510(k) Submission Details - K260106

510(k) Number K260106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2026
Decision Date August 24, 2026
Days to Decision 222 days
Submission Type Traditional
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
100d slower than avg
Panel avg: 122d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 Consultant

DuVal & Associates, P.A.
Jessica Czamanski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 773
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K260106.
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K262344 · TriMed, Inc. · Aug 2026
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K253858 · T.A.G. Medical Products Corporation, Ltd. · Aug 2026
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Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · Arthrex, Inc. · Jun 2026
VEOFIX Snap Off Screw
K253108 · Steps Ortho · Jun 2026
CoLink® & CoLag® Non-Sterile Screws
K261154 · In2bones USA, LLC · May 2026