Cleared Traditional

INFLATABLE BONE TAMP (K090211) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090211 · Cardinal Health, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
154d
Days
Class 2
Risk

K090211 is an FDA 510(k) clearance for the INFLATABLE BONE TAMP. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 154 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 Cardinal Health, Inc. devices

Submission Details

510(k) Number K090211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2009
Decision Date July 01, 2009
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
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 29
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K090211.
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 2010
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005