Cleared Traditional

K160385 - Precision Screw

K160385 is the FDA 510(k) clearance for Precision Screw by Cryptych Pty, Ltd.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K160385 · Cryptych Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
167d
Days
Class 2
Risk

K160385 is an FDA 510(k) clearance for the Precision Screw. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Cryptych Pty, Ltd. (North Sydney, AU). The FDA issued a Cleared decision on July 27, 2016 after a review of 167 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Cryptych Pty, Ltd. devices

Submission Details

510(k) Number K160385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2016
Decision Date July 27, 2016
Days to Decision 167 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 122d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 353
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K160385.
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K153603 · Alphatec Spine, Inc. · Apr 2016
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Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015