Cleared Traditional

K041454 - KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A

K041454 is an FDA 510(k) clearance for KYPHX XPANDER INFLATABLE BONE TAMPS MOD..., 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 38-day FDA review.

K041454 · Kyphon, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
38d
Days
Class 2
Risk

K041454 is an FDA 510(k) clearance for the KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Kyphon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 38 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.

FDA 510(k) Submission Details - K041454

510(k) Number K041454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date July 09, 2004
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 606
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K041454.
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · Future Medical Systems, SA · Jan 2005
ARTHROJET XT
K041233 · Hydrocision, Inc. · Jul 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · Medtronic Sofamor Danek, Inc. · Jul 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · Disc-O-Tech Medical Technologies, Ltd. · Jun 2004
NUCLEOTOME PROBE SET, MODEL 21200
K040919 · Clarus Medical, LLC · Jun 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · Disc-O-Tech Medical Technologies, Ltd. · May 2004