Cleared Special

K261154 - CoLink & CoLag Non-Sterile Screws

K261154 is the FDA 510(k) clearance for CoLink & CoLag Non-Sterile Screws by In2bones USA, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 52-day FDA review.

K261154 · In2bones USA, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
52d
Days
Class 2
Risk

K261154 is an FDA 510(k) clearance for the CoLink® & CoLag® Non-Sterile Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by In2bones USA, LLC (Cordova, US). The FDA issued a Cleared decision on May 30, 2026 after a review of 52 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 In2bones USA, LLC devices

Submission Details

510(k) Number K261154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2026
Decision Date May 30, 2026
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - HWC Screw, Fixation, Bone

All 552
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K261154.
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