Cleared Special

K123771 - KYPHON EXPRESS II INFLATABLE BONE TAMPS

K123771 is an FDA 510(k) clearance for KYPHON EXPRESS II INFLATABLE BONE TAMPS, manufactured by Medtronic. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 14-day FDA review.

K123771 · Medtronic · Orthopedic device
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Dec 2012
Decision
14d
Days
Class 2
Risk

K123771 is an FDA 510(k) clearance for the KYPHON EXPRESS II INFLATABLE BONE TAMPS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medtronic (Sunnyvale, US). The FDA issued a Cleared decision on December 21, 2012 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic devices

FDA 510(k) Submission Details - K123771

510(k) Number K123771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2012
Decision Date December 21, 2012
Days to Decision 14 days
Submission Type Special
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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 536
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K123771.
STRYKER CROSSFLOW ARTHROSCOPY PUMP
K123441 · Stryker Endoscopy · Jan 2013
ASAP MUITISCOPE
K121261 · Asap Endoscopic Products GmbH · Jan 2013
FLEXLITE CAMERA
K122134 · Spine View, Inc. · Dec 2012
XTOOL
K122861 · Ouroboros Medical · Dec 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · Vertiflex, Inc. · Nov 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · Theken Spine, LLC · Aug 2012