Cleared Special

K000153 - ARTHRO-SURGIMAT-A103

K000153 is an FDA 510(k) clearance for ARTHRO-SURGIMAT-A103, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 21-day FDA review.

K000153 · W.O.M. World of Medicine GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
21d
Days
Class 2
Risk

K000153 is an FDA 510(k) clearance for the ARTHRO-SURGIMAT-A103. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Mansfield, US). The FDA issued a Cleared decision on February 8, 2000 after a review of 21 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 - K000153

510(k) Number K000153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date February 08, 2000
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K000153.
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
K000046 · Richard Wolf Medical Instruments Corp. · Mar 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · Richard Wolf Medical Instruments Corp. · Mar 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · Endius, Inc. · Feb 2000
AED ARTHROSCOPE
K991656 · National Advanced Endoscopy Devices, Inc. · Dec 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · KARL STORZ Endoscopy-America, Inc. · Nov 1999
METRX SYSTEM
K993021 · Surgical Navigation Technologies, Inc. · Nov 1999
K000153 · ARTHRO-SURGIMAT-A103
Download PDF FDA Summary W.O.M. World of Medic…