Cleared Traditional

K110592 - 3.7MM/5.0MM DYNAMIC LOCKING SCREW

K110592 is an FDA 510(k) clearance for 3.7MM/5.0MM DYNAMIC LOCKING SCREW, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K110592 · Synthes (Usa) · Orthopedic device
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Jul 2011
Decision
145d
Days
Class 2
Risk

K110592 is an FDA 510(k) clearance for the 3.7MM/5.0MM DYNAMIC LOCKING SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 25, 2011 after a review of 145 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) devices

FDA 510(k) Submission Details - K110592

510(k) Number K110592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date July 25, 2011
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K110592.
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799 · Ascension Orthopedic · Aug 2011
METASURG SUBTALAR IMPLANT
K111265 · Metasurg · Aug 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · Parcus Medical, LLC · Jul 2011
METASURG DIGIFUSE IMPLANT
K111536 · Metasurg · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011
PRO FIXATION SYSTEM
K110538 · Synovis Orthopedic & Woundcare · Jul 2011