Cleared Traditional

PRO FIXATION SYSTEM (K110538) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110538 · Synovis Orthopedic & Woundcare · Orthopedic device
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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

Submission Details

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.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K110538.
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011
MICROSUTURE ANCHORS
K112237 · Arthrex, Inc. · Sep 2011
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K110592 · Synthes (Usa) · Jul 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
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K101696 · Zimmer, Inc. · Sep 2010