Cleared Traditional

PYXIS 3D Titanium Cervical Cage system (K241738) - FDA 510(k) Clearance

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

K241738 · GS Medical Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
64d
Days
Class 2
Risk

K241738 is an FDA 510(k) clearance for the PYXIS 3D Titanium Cervical Cage system. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by GS Medical Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on August 20, 2024 after a review of 64 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 GS Medical Co., Ltd. devices

Submission Details

510(k) Number K241738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2024
Decision Date August 20, 2024
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K241738.
aprevo® Cervical ACDF
K242260 · Carlsmed, Inc. · Nov 2024
ZSFab Cervical Interbody System
K242734 · Zsfab · Nov 2024
Gemini Cervical Fusion Cage System
K242195 · ZheJiang Decans Medical Devices Co., Ltd. · Nov 2024
ARTFX MEDICAL Cervical PEEK Cages
K240893 · Artfx Medical · Jun 2024
Spectrum Spine Cervical Cage System
K240838 · Spectrum Spine, Inc. · May 2024
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
K241396 · Ulrich Medical USA, Inc. · May 2024