Cleared Special

K263116 - OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

K263116 is an FDA 510(k) clearance for OsteoCentric Technologies Cannulated an..., manufactured by OsteoCentric Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 28-day FDA review.

K263116 · OsteoCentric Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
28d
Days
Class 2
Risk

K263116 is an FDA 510(k) clearance for the OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on October 2, 2026 after a review of 28 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 OsteoCentric Technologies devices

FDA 510(k) Submission Details - K263116

510(k) Number K263116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2026
Decision Date October 02, 2026
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Peers - HWC Screw, Fixation, Bone

All 1016
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K263116.
Arthrex Beaming System
K262975 · Arthrex, Inc. · Sep 2026
DynaNail Helix® Fixation System
K260995 · MedShape, Inc. · Sep 2026
F.A.S.T Screw
K254280 · Steps Ortho · Sep 2026
ActivaScrew™ Cannulated COM
K261057 · Bioretec, Ltd. · Sep 2026
OsteoCoil™ GT Active Compression System
K260106 · Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Aug 2026
Large Compression Screws
K262344 · TriMed, Inc. · Aug 2026