Cleared Traditional

K233893 - AlphaVent Knotless SP PEEK Anchor

K233893 is the FDA 510(k) clearance for AlphaVent Knotless SP PEEK Anchor by Stryker Endoscopy. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K233893 · Stryker Endoscopy · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
48d
Days
Class 2
Risk

K233893 is an FDA 510(k) clearance for the AlphaVent Knotless SP PEEK Anchor. 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 Endoscopy (San Jose, US). The FDA issued a Cleared decision on January 25, 2024 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Endoscopy devices

Submission Details

510(k) Number K233893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2023
Decision Date January 25, 2024
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K233893.
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K230891 · Healthium Medtech Limited · Dec 2023