Cleared Traditional

SPICCA Cervical Fusion Cages (K230607) - FDA 510(k) Clearance

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

K230607 · Southern Medical (Pty) , Ltd. · Orthopedic device
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Aug 2023
Decision
164d
Days
Class 2
Risk

K230607 is an FDA 510(k) clearance for the SPICCA Cervical Fusion Cages. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Southern Medical (Pty) , Ltd. (Irene, ZA). The FDA issued a Cleared decision on August 14, 2023 after a review of 164 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 Southern Medical (Pty) , Ltd. devices

Submission Details

510(k) Number K230607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2023
Decision Date August 14, 2023
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 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 K230607.
VariLift®-C Interbody Fusion System
K231076 · Wenzel Spine, Inc. · Sep 2023
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
K222988 · Ht Medical D.B.A. Xenix Medical · Sep 2023
ZSFab Cervical Interbody System
K232150 · Zsfab, Inc. · Aug 2023
CarboClear Cervical Cage System, CarboClear Cervical VBR System
K222874 · Carbofix Orthpedics , Ltd. · Jul 2023
NuVasive CoRoent Small Interbody System
K231735 · Nu Vasive, Incorporated · Jul 2023
Integral Titanium Cervical Interbody
K222015 · Nvision Biomedical Technologies, Inc. · Jul 2023