Cleared Traditional

K090303 - XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004

K090303 is an FDA 510(k) clearance for XTEND-ST NUCLEUS REMOVAL SYSTEM, manufactured by Corespine Technologies, LLC. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K090303 · Corespine Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
83d
Days
Class 2
Risk

K090303 is an FDA 510(k) clearance for the XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Corespine Technologies, LLC (Minneapolis, US). The FDA issued a Cleared decision on April 30, 2009 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

FDA 510(k) Submission Details - K090303

510(k) Number K090303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2009
Decision Date April 30, 2009
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 656
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K090303.
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · Arthrex, Inc. · Aug 2009
MAXMORESPINE SPINAL SYSTEM
K090132 · Hoogland Spine Products, GmbH · Jun 2009
PERCUTANEOUS DISCECTOMY SYSTEM
K090815 · Laurimed, LLC · May 2009
ENSPIRE DEBRIDER SYSTEM
K090278 · Spine View, Inc. · Apr 2009
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
K083161 · Conmed Linvatec · Mar 2009
TIGER DISCECTOMY DEVICE
K081240 · Spinal Devices, LLC · Feb 2009
K090303 · XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
Download PDF FDA Summary Corespine Technologie…