Cleared Traditional

K102397 - KYPHON XPEDE BONE CEMENT

K102397 is the FDA 510(k) clearance for KYPHON XPEDE BONE CEMENT by Medtronic. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K102397 · Medtronic · Orthopedic device
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Feb 2011
Decision
188d
Days
Class 2
Risk

K102397 is an FDA 510(k) clearance for the KYPHON XPEDE BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Medtronic (Sunnyvale, US). The FDA issued a Cleared decision on February 28, 2011 after a review of 188 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 devices

Submission Details

510(k) Number K102397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date February 28, 2011
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 49
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K102397.
IVAS BALLOON CATHETER
K113154 · Stryker Corporation · Jan 2012
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · Medos International SARL · Dec 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · Stryker Corporation · Jun 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · Arthrocare Corp. · Feb 2011
AVAMAX VERTEBRAL BALLOON
K103064 · Care Fusion · Jan 2011
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479 · Arthrocare Corp. · Sep 2010