Cleared Special

K034037 - SKY BONE EXPANDER SYSTEM

K034037 is an FDA 510(k) clearance for SKY BONE EXPANDER 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.

K034037 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
30d
Days
Class 2
Risk

K034037 is an FDA 510(k) clearance for the SKY BONE EXPANDER SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Washington, US). The FDA issued a Cleared decision on January 28, 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.

View all Disc-O-Tech Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K034037

510(k) Number K034037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date January 28, 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 469
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K034037.
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · Disc-O-Tech Medical Technologies, Ltd. · May 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
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
K032358 · Disc-O-Tech Medical Technologies, Ltd. · Dec 2003
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
K032473 · Stryker Instruments · Nov 2003
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · Richard Wolf Medical Instruments Corp. · Oct 2003