Cleared Traditional

K040483 - EQUESTRA FLUID DELIVERY SYSTEM

K040483 is an FDA 510(k) clearance for EQUESTRA FLUID DELIVERY SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K040483 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
149d
Days
Class 2
Risk

K040483 is an FDA 510(k) clearance for the EQUESTRA FLUID DELIVERY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 149 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 Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K040483

510(k) Number K040483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2004
Decision Date July 23, 2004
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 529
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K040483.
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · Smith & Nephew, Inc. · Jan 2005
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · Future Medical Systems, SA · Jan 2005
ARTHROJET XT
K041233 · Hydrocision, Inc. · Jul 2004
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
K041454 · Kyphon, Inc. · Jul 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · Disc-O-Tech Medical Technologies, Ltd. · Jun 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · Disc-O-Tech Medical Technologies, Ltd. · May 2004