Cleared Traditional

AnyPlus Navigated Instruments System (K243073) - FDA 510(k) Clearance

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

K243073 · GS Medical Co., Ltd. · Orthopedic device
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Dec 2024
Decision
70d
Days
Class 2
Risk

K243073 is an FDA 510(k) clearance for the AnyPlus Navigated Instruments System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by GS Medical Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on December 6, 2024 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 GS Medical Co., Ltd. devices

Submission Details

510(k) Number K243073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date December 06, 2024
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K243073.
TMINI Miniature Robotic System
K243481 · THINK Surgical, Inc. · Jan 2025
ExcelsiusGPS® Instruments
K243671 · Globus Medical, Inc. · Dec 2024
Remex Spine Surgery Navigation Instrument
K243560 · Remex Medical Corp. · Dec 2024
TMINI Miniature Robotic System
K243285 · THINK Surgical, Inc. · Nov 2024
Mako Shoulder Application (1.0)
K242373 · Mako Surgical Corp. · Nov 2024
ROSA® Knee System
K242864 · Orthosoft Inc. (d/b/a) Zimmer CAS · Oct 2024