Cleared Traditional

K250092 - HC Biologics Osteopoint Spinal Fixation...

K250092 is an FDA 510(k) clearance for HC Biologics Osteopoint Spinal Fixation..., manufactured by HC Biologics, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K250092 · HC Biologics, LLC · Orthopedic device
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Mar 2025
Decision
72d
Days
Class 2
Risk

K250092 is an FDA 510(k) clearance for the HC Biologics Osteopoint Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by HC Biologics, LLC (Miami, US). The FDA issued a Cleared decision on March 27, 2025 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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

FDA 510(k) Submission Details - K250092

510(k) Number K250092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2025
Decision Date March 27, 2025
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 715
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K250092.
Annex® 2 Adjacent Level System
K251131 · Spine Wave, Inc. · Jun 2025
COLONNADE Posterior Screw Fixation System
K250582 · CG Bio Co., Ltd. · May 2025
Eminent Spine 3D Titanium Pedicle Screw System
K241663 · Eminent Spine · Apr 2025
VADER® Pedicle System and VADER®one Pedicle System
K242900 · Icotec AG · Feb 2025
Primus Spinal Fixation System
K243916 · Spinal Elements, Inc. · Feb 2025
Tiger 2 System
K243908 · Zavation Medical Products, LLC · Feb 2025