Cleared Traditional

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725) - FDA 510(k) Clearance

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

K232725 · Suzhou Endophix Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
57d
Days
Class 2
Risk

K232725 is an FDA 510(k) clearance for the Javelot Ti Suture Anchor, Javelot Ti-D 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 Suzhou Endophix Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 2, 2023 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 Suzhou Endophix Co., Ltd. devices

Submission Details

510(k) Number K232725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2023
Decision Date November 02, 2023
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 K232725.
Iconix Anchor
K233468 · Riverpoint Medical · Nov 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · Healthium Medtech Limited · Nov 2023
Arthrex FiberTak Suture Anchor
K232742 · Arthrex, Inc. · Nov 2023
Knotilus+ PEEK Knotless Anchor
K232683 · Stryker Endoscopy · Oct 2023
Shadow Knotless All-Suture Anchors
K233258 · Responsive Arthroscopy, LLC · Oct 2023
JuggerKnot Soft Anchor OC
K232411 · Riverpoint Medical, LLC · Oct 2023