Cleared Traditional

K200226 - RetroFix

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

K200226 · Retrofix Screws, LLC · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K200226

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.

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 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 942
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K200226.
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K201319 · Medline Industires, Inc. · Jun 2020