Cleared Traditional

K110538 - PRO FIXATION SYSTEM

K110538 is an FDA 510(k) clearance for PRO FIXATION SYSTEM, manufactured by Synovis Orthopedic & Woundcare. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K110538 · Synovis Orthopedic & Woundcare · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
137d
Days
Class 2
Risk

K110538 is an FDA 510(k) clearance for the PRO FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synovis Orthopedic & Woundcare (Irvine, US). The FDA issued a Cleared decision on July 12, 2011 after a review of 137 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 Synovis Orthopedic & Woundcare devices

FDA 510(k) Submission Details - K110538

510(k) Number K110538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date July 12, 2011
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
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 764
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K110538.
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · Parcus Medical, LLC · Jul 2011
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K110592 · Synthes (Usa) · Jul 2011
AAP CANNULATED SCREWS
K111316 · Aap Implantate AG · Jul 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658 · Medartis AG · Jun 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · Synthes USA Products, LLC · May 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011