Cleared Traditional

K161334 - RASL Repair Kit

K161334 is an FDA 510(k) clearance for RASL Repair Kit, manufactured by Radicle Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K161334 · Radicle Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2017
Decision
273d
Days
Class 2
Risk

K161334 is an FDA 510(k) clearance for the RASL Repair Kit. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Radicle Orthopaedics, Inc. (New York, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 273 days - an extended review 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: 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 Radicle Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K161334

510(k) Number K161334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date February 09, 2017
Days to Decision 273 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
151d slower than avg
Panel avg: 122d · This submission: 273d
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 Peers - HWC Screw, Fixation, Bone

All 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161334.
BePOD Cannulated Arthrodesis Screws
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