Cleared Traditional

K011454 - SPINE SCOPE

K011454 is an FDA 510(k) clearance for SPINE SCOPE, manufactured by Clarus Medical, LLC. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K011454 · Clarus Medical, LLC · Orthopedic device
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Dec 2001
Decision
216d
Days
Class 2
Risk

K011454 is an FDA 510(k) clearance for the SPINE SCOPE, MODEL 2180. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Clarus Medical, LLC (Minneapolis, US). The FDA issued a Cleared decision on December 13, 2001 after a review of 216 days - an extended review 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: 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 Clarus Medical, LLC devices

FDA 510(k) Submission Details - K011454

510(k) Number K011454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date December 13, 2001
Days to Decision 216 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
94d slower than avg
Panel avg: 122d · This submission: 216d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K011454.
ENDIUS FLEXTIP BLADE
K022578 · Endius, Inc. · Aug 2002
ENDIUS ATAVI SYSTEM
K021748 · Endius, Inc. · Jun 2002
POWER TEK II
K020761 · Biomet, Inc. · Apr 2002
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · Alliance Medical Corp. · Nov 2001
REPROCESSED ATHROSCOPICS BURS
K012605 · Alliance Medical Corp. · Nov 2001