Cleared Traditional

K260340 - HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (FDA 510(k) Clearance)

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

K260340 · HC Biologics, LLC · Orthopedic device
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Apr 2026
Decision
70d
Days
Class 2
Risk

K260340 is an FDA 510(k) clearance for the HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAG.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by HC Biologics, LLC (Miami, US). The FDA issued a Cleared decision on April 13, 2026 after a review of 70 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 HC Biologics, LLC devices

Submission Details

510(k) Number K260340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date April 13, 2026
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 345
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K260340.
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · Zsfab, Inc. · Apr 2026
ORIO-3D Cage System
K253260 · SpineCraft · Apr 2026
MOD-C
K242303 · Orthomod, LLC · Apr 2026
Flex-Z™ Cervical Cage
K252432 · Spinepoint, LLC · Mar 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · NanoHive Medical, LLC · Feb 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · Curiteva, Inc. · Jan 2026