Cleared Traditional

Expandable Lumbar Fusion Cage (Type I,Type II) (K232069) - FDA 510(k) Clearance

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

K232069 · Shanghai Reach Medical Instrument Co, Ltd. · Orthopedic device
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Nov 2023
Decision
140d
Days
Class 2
Risk

K232069 is an FDA 510(k) clearance for the Expandable Lumbar Fusion Cage (Type I,Type II). 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 Reach Medical Instrument Co, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 29, 2023 after a review of 140 days - within the typical 510(k) review window.

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 Reach Medical Instrument Co, Ltd. devices

Submission Details

510(k) Number K232069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2023
Decision Date November 29, 2023
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Eva Li

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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K232069.
Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System
K230872 · Shanghai Sanyou Medical Co, Ltd. · Dec 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
K231743 · Corelink, LLC · Dec 2023
TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System
K232611 · Life Spine, Inc. · Nov 2023
Peridot-EX Expandable Intervertebral Body Fusion System
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Calibrate CCX Interbody System
K232504 · Alphatec Spine, Inc. · Oct 2023
CONDUIT™ ATP Inserters
K232014 · Enztec Limited · Sep 2023