Cleared Traditional

K093677 - STRYKER ARTHROSCOPE

K093677 is the FDA 510(k) clearance for STRYKER ARTHROSCOPE by Stryker Endoscopy. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K093677 · Stryker Endoscopy · Orthopedic device
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Mar 2010
Decision
98d
Days
Class 2
Risk

K093677 is an FDA 510(k) clearance for the STRYKER ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 98 days - within the typical 510(k) review window.

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 Stryker Endoscopy devices

Submission Details

510(k) Number K093677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date March 05, 2010
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 379
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K093677.
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · Medtronic · Dec 2012
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
K093471 · KARL STORZ Endoscopy-America, Inc. · Oct 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · Medtronic · Oct 2010
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · Arthrex, Inc. · Aug 2009
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
K080617 · Richard Wolf Medical Instruments Corp. · Jun 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · Biomet Orthopedics, Inc. · Jan 2008