Cleared Traditional

K162153 - Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

K162153 is an FDA 510(k) clearance for Integra CAPTURE Screw System & Integra ..., manufactured by Ascension Orthopedics. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K162153 · Ascension Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2017
Decision
346d
Days
Class 2
Risk

K162153 is an FDA 510(k) clearance for the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ascension Orthopedics (Austin, US). The FDA issued a Cleared decision on July 14, 2017 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ascension Orthopedics devices

FDA 510(k) Submission Details - K162153

510(k) Number K162153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date July 14, 2017
Days to Decision 346 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
224d slower than avg
Panel avg: 122d · This submission: 346d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K162153.
ExsoMed ArcPhix and ExsoMed ArrowPhix
K171407 · Exsomed Holding Company, LLC · Aug 2017
TalarLift STS
K170624 · Fusion Orthopedics, LLC · Aug 2017
FuzeFix Screw System
K170038 · Fusion Orthopedics, LLC · Aug 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Cannulated Screws Neoortho
K162874 · Neoortho Produtos Ortopedicos S/A · Jun 2017