Cleared Traditional

K113028 - MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS

K113028 is an FDA 510(k) clearance for MEDISISS REPROCESSED ARTHROSCOPIC SHAVE..., manufactured by Medisiss. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K113028 · Medisiss · Orthopedic device
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Dec 2011
Decision
70d
Days
Class 2
Risk

K113028 is an FDA 510(k) clearance for the MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medisiss (Redmond, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 70 days - a notably fast clearance cycle.

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

View all Medisiss devices

FDA 510(k) Submission Details - K113028

510(k) Number K113028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date December 20, 2011
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.

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 550
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K113028.
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K113362 · Spine View, Inc. · Feb 2012
ENSPIRE DEBRIDER SYSTEM
K110992 · Spine View, Inc. · Oct 2011
KYPHON INFLATION SYRINGE
K103231 · Medtronic Spine, LLC · Jan 2011
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K093471 · KARL STORZ Endoscopy-America, Inc. · Oct 2010