Cleared Traditional

K210159 - IntraLock System

K210159 is an FDA 510(k) clearance for IntraLock System, manufactured by Fusion Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K210159 · Fusion Orthopedics, LLC · Orthopedic device
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Jul 2021
Decision
183d
Days
Class 2
Risk

K210159 is an FDA 510(k) clearance for the IntraLock System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on July 23, 2021 after a review of 183 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 Fusion Orthopedics, LLC devices

FDA 510(k) Submission Details - K210159

510(k) Number K210159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2021
Decision Date July 23, 2021
Days to Decision 183 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
61d slower than avg
Panel avg: 122d · This submission: 183d
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 690
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K210159.
PAO Cortical Screw
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TriMed Threaded Intramedullary Nail System
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K211290 · OsteoCentric Technologies · Aug 2021
Medline UNITE® Digital Fusion Screw System
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Arthrex Beveled FT Screws
K210994 · Arthrex, Inc. · Jun 2021
Axis Charcot Fixation System
K211261 · Extremity Medical, LLC · May 2021