Cleared Special

K112737 - TIGER HEADLESS CANNULATED SCREWS

K112737 is an FDA 510(k) clearance for TIGER HEADLESS CANNULATED SCREWS, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 30-day FDA review.

K112737 · Trilliant Surgical, Ltd. · Orthopedic device
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Oct 2011
Decision
30d
Days
Class 2
Risk

K112737 is an FDA 510(k) clearance for the TIGER HEADLESS CANNULATED SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Round Rock, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 30 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 Trilliant Surgical, Ltd. devices

FDA 510(k) Submission Details - K112737

510(k) Number K112737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date October 20, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
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 726
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K112737.
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
SYNTHES CORTICAL SCREWS
K112583 · Synthes USA Products, LLC · Dec 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011