Cleared Traditional

K182949 - Healix Compression Screw System

K182949 is the FDA 510(k) clearance for Healix Compression Screw System by Nvision Biomedical Technologies, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K182949 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Dec 2018
Decision
42d
Days
Class 2
Risk

K182949 is an FDA 510(k) clearance for the Healix™ Compression Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on December 4, 2018 after a review of 42 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 Nvision Biomedical Technologies, LLC devices

Submission Details

510(k) Number K182949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2018
Decision Date December 04, 2018
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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

Watershed Idea Foundry
Jeffrey Brittan

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 552
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K182949.
Arthrex Compression FT Screws
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K182684 · Fusion Orthopedics, LLC · Nov 2018
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