Cleared Traditional

Stativ® Knotted UHMWPE Suture Anchor (K223889) - FDA 510(k) Clearance

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

K223889 · Healthium Medtech Limited · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
85d
Days
Class 2
Risk

K223889 is an FDA 510(k) clearance for the Stativ® Knotted UHMWPE 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 Healthium Medtech Limited (Bangalore, IN). The FDA issued a Cleared decision on March 22, 2023 after a review of 85 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 Healthium Medtech Limited devices

Submission Details

510(k) Number K223889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2022
Decision Date March 22, 2023
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K223889.
FiberTak Suture Anchor
K230568 · Arthrex, Inc. · Apr 2023
Fixone All Suture Anchor
K222423 · Aju Pharm Co., Ltd. · Mar 2023
Tigon Medical Gryphon Anchor Line
K220464 · Tigon Medical · Mar 2023
Aevumed RAPID Suture Anchors
K223878 · Aevumed, Inc. · Mar 2023
Arthrex Knotless FiberTak Suture Anchor
K230433 · Arthrex, Inc. · Mar 2023
SINEFIX
K220966 · BAAT Medical Products B.V. · Mar 2023