Cleared Traditional

K203485 - SnugFit All-Suture Anchor

K203485 is the FDA 510(k) clearance for SnugFit All-Suture Anchor by Medacta International S.A.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K203485 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
53d
Days
Class 2
Risk

K203485 is an FDA 510(k) clearance for the SnugFit All-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 Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on January 19, 2021 after a review of 53 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 Medacta International S.A. devices

Submission Details

510(k) Number K203485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2020
Decision Date January 19, 2021
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 Consultant

Medacta USA
Chris Lussier

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K203485.
JuggerKnot Soft Anchor
K203740 · Riverpoint Medical · Feb 2021
TenoTac Soft Tissue Fixation System
K203385 · Paragon 28, Inc. · Feb 2021
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
K203794 · Medos International SARL · Feb 2021
Button Loop
K202291 · Yunyi (Beijing) Medical Device Co., Ltd. · Jan 2021
Fixone All Suture Anchor
K192709 · Aju Pharm Co., Ltd. · Dec 2020
Arthrex FiberTak Suture Anchor
K203268 · Arthrex, Inc. · Nov 2020