Cleared Traditional

K230397 - Cut Screw - Percutaneous Compression Screw

K230397 is the FDA 510(k) clearance for Cut Screw - Percutaneous Compression Screw by GM Dos Reis Industria e Comercio Ltda.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K230397 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device
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Jun 2023
Decision
118d
Days
Class 2
Risk

K230397 is an FDA 510(k) clearance for the Cut Screw - Percutaneous Compression Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on June 12, 2023 after a review of 118 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 GM Dos Reis Industria e Comercio Ltda. devices

Submission Details

510(k) Number K230397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2023
Decision Date June 12, 2023
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K230397.
Forma Medical Headless Compression Screw
K230945 · Forma Medical, Inc. · Jul 2023
OsteoCentric ACL Fixation System
K230595 · OsteoCentric Technologies · Jun 2023
Bone Bolt System
K230867 · University of Utah, Department of Orthopaedics · Jun 2023
Acumed Acutrak 3 Headless Compression Screw System
K230744 · Acumed, LLC · Jun 2023
Hand Trauma Threaded Nail System
K230908 · Skeletal Dynamics, Inc. · Apr 2023
SimpliFix Hip System
K230053 · Stabiliz Orthopaedics, Inc. · Apr 2023