Cleared Traditional

PEEK Spinal Infusion Cage (K223776) - FDA 510(k) Clearance

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

K223776 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
77d
Days
Class 2
Risk

K223776 is an FDA 510(k) clearance for the PEEK Spinal Infusion Cage. 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 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on March 3, 2023 after a review of 77 days - a notably fast clearance 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: 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 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. devices

Submission Details

510(k) Number K223776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2022
Decision Date March 03, 2023
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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

Sinow Medical AS
Xiaoqing Xue

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 K223776.
Calibrate LTX Interbody System
K223611 · Alphatec Spine, Inc. · Mar 2023
DeGen Impulse AM™ System
K223418 · Degen Medical · Mar 2023
CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments
K223688 · Medos International S?rl · Mar 2023
X-Pac Expandable LLIF Cage System
K223174 · Expanding Innovations, Inc. · Feb 2023
PathLoc-TA Expandable Lumbar Cage System
K223474 · L & K Biomed Co., Ltd. · Jan 2023
LumiVy™ Lumbar IBF System
K223412 · Vy Spine, LLC · Jan 2023