Cleared Traditional

K081240 - TIGER DISCECTOMY DEVICE

K081240 is an FDA 510(k) clearance for TIGER DISCECTOMY DEVICE, manufactured by Spinal Devices, LLC. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K081240 · Spinal Devices, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
302d
Days
Class 2
Risk

K081240 is an FDA 510(k) clearance for the TIGER DISCECTOMY DEVICE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Spinal Devices, LLC (Apple Valley, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081240

510(k) Number K081240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date February 27, 2009
Days to Decision 302 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
180d slower than avg
Panel avg: 122d · This submission: 302d
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 K081240.
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
K090303 · Corespine Technologies, LLC · Apr 2009
ENSPIRE DEBRIDER SYSTEM
K090278 · Spine View, Inc. · Apr 2009
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
K083161 · Conmed Linvatec · Mar 2009
VISIONSENSE STEREOSCOPIC VISION SYSTEM
K082355 · Visionsense, Ltd. · Dec 2008
SURGVIEW INTEGRATED VISUALIZATION SYSTEM
K082293 · Biovision Technologies, LLC · Sep 2008
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
K082194 · Laurimed, LLC · Aug 2008
K081240 · TIGER DISCECTOMY DEVICE
Download PDF FDA Summary Spinal Devices, LLC