Cleared Traditional

K112583 - SYNTHES CORTICAL SCREWS

K112583 is an FDA 510(k) clearance for SYNTHES CORTICAL SCREWS, manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K112583 · Synthes USA Products, LLC · Orthopedic device
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Dec 2011
Decision
90d
Days
Class 2
Risk

K112583 is an FDA 510(k) clearance for the SYNTHES CORTICAL SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on December 5, 2011 after a review of 90 days - within the typical 510(k) review window.

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 Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K112583

510(k) Number K112583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2011
Decision Date December 05, 2011
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 Peers - HWC Screw, Fixation, Bone

All 966
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K112583.
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
RENOVIS CANNULATED SCREW SYSTEM
K113084 · Renovis Surgical Technologies, LLC · Dec 2011
DISCO SUBTALAR IMPLANT
K111834 · Trilliant Surgical, Ltd. · Dec 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908 · Biomet Microfixation, Inc. · Nov 2011
TIGER HEADLESS CANNULATED SCREWS
K112737 · Trilliant Surgical, Ltd. · Oct 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · Smith & Nephew, Inc. · Oct 2011