Cleared Traditional

K230088 - Ankle Truss System (ATS) (FDA 510(k) Clearance)

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

K230088 · 4Web Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
434d
Days
Class 2
Risk

K230088 is an FDA 510(k) clearance for the Ankle Truss System (ATS). Classified as Ankle Fusion Cage (product code SAI), Class II - Special Controls.

Submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on March 21, 2024 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all 4Web Medical, Inc. devices

Submission Details

510(k) Number K230088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2023
Decision Date March 21, 2024
Days to Decision 434 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
312d slower than avg
Panel avg: 122d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAI Ankle Fusion Cage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
Definition Intended For Use As An Accessory To A Tibiotalocalcaneal Intramedullary (im) Rod As Part Of A Fusion Construct For Failed Ankle Arthrodesis Or Failed Ankle Arthroplasty. Not Intended For Standalone Use.
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

DuVal & Associates, P.A.
Kathy Herzog

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.