Cleared Traditional

K180377 - Fracture and Correction System

K180377 is an FDA 510(k) clearance for Fracture and Correction System, manufactured by In2bones USA, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K180377 · In2bones USA, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2018
Decision
128d
Days
Class 2
Risk

K180377 is an FDA 510(k) clearance for the Fracture and Correction System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on June 20, 2018 after a review of 128 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 In2bones USA, LLC devices

FDA 510(k) Submission Details - K180377

510(k) Number K180377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2018
Decision Date June 20, 2018
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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

Mrc-X, LLC
Christine Scifert

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 939
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180377.
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