Cleared Traditional

K981251 - KYPHON INFLATABLE BONE TAMP

K981251 is an FDA 510(k) clearance for KYPHON 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 87-day FDA review.

K981251 · Kyphon, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
87d
Days
Class 2
Risk

K981251 is an FDA 510(k) clearance for the KYPHON INFLATABLE BONE TAMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Kyphon, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 2, 1998 after a review of 87 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 - K981251

510(k) Number K981251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date July 02, 1998
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K981251.
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · Electro-Biology, Inc. · Oct 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · Linvatec Corp. · Aug 1998
UNIVERSAL DRIVE SYSTEM
K981269 · Linvatec Corp. · Jun 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · Smith & Nephew, Inc. · May 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · Richard Wolf Medical Instruments Corp. · Mar 1998