Cleared Special

K261217 - AnyPlus II Spinal Fixation System

K261217 is an FDA 510(k) clearance for AnyPlus II Spinal Fixation System, manufactured by GS Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 171-day FDA review.

K261217 · GS Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
171d
Days
Class 2
Risk

K261217 is an FDA 510(k) clearance for the AnyPlus II Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by GS Medical Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on October 2, 2026 after a review of 171 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GS Medical Co., Ltd. devices

FDA 510(k) Submission Details - K261217

510(k) Number K261217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2026
Decision Date October 02, 2026
Days to Decision 171 days
Submission Type Special
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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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

RQMIS, Inc.
Barry Sands

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.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K261217.
NOVIX Pedicle Screw System
K263062 · Tdm Co., Ltd. · Oct 2026
Duet™ Spinal Fixation System
K262712 · Duet Spine Holdings, LLC · Sep 2026
SAS MIS Pelvic Incidence Rods
K263172 · Spinal Alignment Solutions, Inc. · Sep 2026
Kentrospine Viktr-MIS® Pedicle screw system
K252139 · Rivarp Medical Pvt., Ltd. · Sep 2026
iFuse Granite Onyx™ Implant System
K262067 · SI-BONE, Inc. · Sep 2026
FRAXION Spinal Fixation System
K262091 · Ortler Global Tibbi Gerecler Anonim Sirketi · Sep 2026