Cleared Traditional

K010246 - KYPHX INFLATABLE BONE TAMP

K010246 is an FDA 510(k) clearance for KYPHX INFLATABLE BONE TAMP, manufactured by Kyphon, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K010246 · Kyphon, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
19d
Days
Class 2
Risk

K010246 is an FDA 510(k) clearance for the KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP,.... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Kyphon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 19 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kyphon, Inc. devices

FDA 510(k) Submission Details - K010246

510(k) Number K010246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2001
Decision Date February 14, 2001
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
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 452
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K010246.
SHAVER ABLATOR
K002088 · Linvatec Corp. · Mar 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
K003893 · Oratec Interventions, Inc. · Mar 2001
DYONICS CONTROL RF SYSTEM
K003572 · Smith & Nephew, Inc. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · Ebi, L.P. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · Ebi, L.P. · Jan 2001
METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000