Cleared Traditional

CurvaFix Intramedullary Rodscrew System (K180050) - FDA 510(k) Clearance

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

K180050 · Curvafix, Inc. · Orthopedic device
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Mar 2019
Decision
417d
Days
Class 2
Risk

K180050 is an FDA 510(k) clearance for the CurvaFix Intramedullary Rodscrew System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Curvafix, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 1, 2019 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Curvafix, Inc. devices

Submission Details

510(k) Number K180050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2018
Decision Date March 01, 2019
Days to Decision 417 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
295d slower than avg
Panel avg: 122d · This submission: 417d
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

Backroads Consulting
Karen E. Warden

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 407
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