Cleared Traditional

K230872 - Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (FDA 510(k) Clearance)

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

K230872 · Shanghai Sanyou Medical Co, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
257d
Days
Class 2
Risk

K230872 is an FDA 510(k) clearance for the Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direct.... Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN). The FDA issued a Cleared decision on December 12, 2023 after a review of 257 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Sanyou Medical Co, Ltd. devices

Submission Details

510(k) Number K230872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2023
Decision Date December 12, 2023
Days to Decision 257 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 885
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K230872.
BEE PLIF Cage
K261067 · NGMedical GmbH · Apr 2026
SCRIPT™ Implant System
K253401 · Globus Medical, Inc. · Apr 2026
SWINGO-3D Lumbar Cage System
K254017 · Implanet · Feb 2026
LUX Expandable Lumbar Interbody System
K253583 · Xenix Medical · Feb 2026
Luna® Ti Interbody Fusion System
K250773 · Spinal Elements, Inc. · Feb 2026
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
K253748 · Life Spine, Inc. · Jan 2026