Cleared Traditional

K243665 - Crius PEEK Suture Anchor System (Thread...

Also marketed or referenced as:
Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor) Crius PEEK Suture Anchor System (Helicoil Anchor) Crius PEEK Suture Anchor System (Pile Anchor)

K243665 is an FDA 510(k) clearance for Crius PEEK Suture Anchor System (Thread..., manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K243665 · ZheJiang Decans Medical Devices Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
65d
Days
Class 2
Risk

K243665 is an FDA 510(k) clearance for the Crius PEEK Suture Anchor System (Thread-Fix 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 ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on January 31, 2025 after a review of 65 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 ZheJiang Decans Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K243665

510(k) Number K243665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date January 31, 2025
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

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 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K243665.
Arthrex TightRope Soft Button, RT
K250424 · Arthrex, Inc. · Mar 2025
WasherCap™ Fixation System
K250238 · Abanza Tecnomed S.L · Feb 2025
SuperBall-RC™
K244015 · Arcuro Medical , Ltd. · Feb 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · Abanza Tecnomed S.L · Jan 2025
Osprey Suture Anchor
K243726 · Responsive Arthroscopy, Inc. · Jan 2025
Argo Knotless GENESYS Anchor
K244025 · Conmed Corporation · Jan 2025