Cleared Traditional

K171465 - Stryker Self-Punching ICONIX

K171465 is the FDA 510(k) clearance for Stryker Self-Punching ICONIX by Stryker. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K171465 · Stryker · Orthopedic device
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Aug 2017
Decision
98d
Days
Class 2
Risk

K171465 is an FDA 510(k) clearance for the Stryker Self-Punching ICONIX. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on August 24, 2017 after a review of 98 days - within the typical 510(k) review window.

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 Stryker devices

Submission Details

510(k) Number K171465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2017
Decision Date August 24, 2017
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 416
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K171465.
Stryker Self-Punching ICONIX
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