Cleared Traditional

CurvaFix IM System (K222505) - FDA 510(k) Clearance

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

K222505 · Curvafix, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
70d
Days
Class 2
Risk

K222505 is an FDA 510(k) clearance for the CurvaFix IM 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 October 27, 2022 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Curvafix, Inc. devices

Submission Details

510(k) Number K222505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2022
Decision Date October 27, 2022
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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

DuVal & Associates, P.A.
Lisa Pritchard

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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K222505.
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
K222967 · Avanti Orthopaedics, Inc. · Nov 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564 · Treace Medical Concepts, Inc. · Nov 2022
Nextra CH Cannulated Hammertoe System
K221610 · Nextremity Solutions, Inc. · Nov 2022
Tandry Compression Screw System
K220359 · Microware Precision Co., Ltd. · Sep 2022
Arthrex Compression FT Pins
K220839 · Arthrex, Inc. · Sep 2022
CAPTIVATE® Compression Screws
K222409 · Globus Medical, Inc. · Sep 2022