Cleared Special

K040939 - SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

K040939 is an FDA 510(k) clearance for SKY BONE EXPANDER SYSTEM (SKY SYSTEM), manufactured by Disc-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 30-day FDA review.

K040939 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
30d
Days
Class 2
Risk

K040939 is an FDA 510(k) clearance for the SKY BONE EXPANDER SYSTEM (SKY SYSTEM). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Herzliya, IL). The FDA issued a Cleared decision on May 12, 2004 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040939

510(k) Number K040939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date May 12, 2004
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 648
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K040939.
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
K041454 · Kyphon, 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
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
K041135 · Depuy Mitek, A Johnson & Johnson Company · May 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · Linvatec Corp. · Feb 2004
SKY BONE EXPANDER SYSTEM
K034037 · Disc-O-Tech Medical Technologies, Ltd. · Jan 2004
K040939 · SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
Download PDF FDA Summary Disc-O-Tech Medical T…