Cleared Special

K110763 - LATARJET CORTICAL SCREW SET

K110763 is an FDA 510(k) clearance for LATARJET CORTICAL SCREW SET, manufactured by T.A.G. Medical Products Corporation, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 24-day FDA review.

K110763 · T.A.G. Medical Products Corporation, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
24d
Days
Class 2
Risk

K110763 is an FDA 510(k) clearance for the LATARJET CORTICAL SCREW SET. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by T.A.G. Medical Products Corporation, Ltd. (Somerset, US). The FDA issued a Cleared decision on April 11, 2011 after a review of 24 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.

FDA 510(k) Submission Details - K110763

510(k) Number K110763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2011
Decision Date April 11, 2011
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 1057
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K110763.
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · Synthes USA Products, LLC · May 2011
STERILE STORM (R) OPERATING KIT
K111001 · Intelligent Orthopaedics, Ltd. · May 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
FLEXFUSION (TM) FIXATION IMPLANT
K110445 · Nextremity Solutions, LLC · Mar 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · Depuy Mitek, A Johnson & Johnson Company · Mar 2011
K110763 · LATARJET CORTICAL SCREW SET
Download PDF FDA Summary T.A.G. Medical Produc…