Cleared Traditional

Footprint Mini PK, 3.5mm Suture Anchor (K233730) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233730 · Smith & Nephew · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
57d
Days
Class 2
Risk

K233730 is an FDA 510(k) clearance for the Footprint Mini PK, 3.5mm Suture 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 Smith & Nephew (Andover, US). The FDA issued a Cleared decision on January 17, 2024 after a review of 57 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 Smith & Nephew devices

Submission Details

510(k) Number K233730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2023
Decision Date January 17, 2024
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K233730.
Iconix Knotless Anchor
K240213 · Riverpoint Medical · Feb 2024
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K240194 · Riverpoint Medical · Feb 2024
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CEPTRE® Knotted UHMWPE Suture PEEK Anchor
K231033 · Healthium Medtech Limited · Jan 2024
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K230891 · Healthium Medtech Limited · Dec 2023
Suture Wing
K233659 · Osteonic Co., Ltd. · Dec 2023