Cleared Traditional

K200226 - RetroFix

K200226 is the FDA 510(k) clearance for RetroFix by Retrofix Screws, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K200226 · Retrofix Screws, LLC · Orthopedic device
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Jun 2020
Decision
148d
Days
Class 2
Risk

K200226 is an FDA 510(k) clearance for the RetroFix. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Retrofix Screws, LLC (Salisbury, US). The FDA issued a Cleared decision on June 26, 2020 after a review of 148 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 Retrofix Screws, LLC devices

Submission Details

510(k) Number K200226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2020
Decision Date June 26, 2020
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 Consultant

Fish & Richardson, P.C.
Keith A Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 567
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K200226.
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