Cleared Traditional

K990911 - MTP ARTHROPUMP DISPOSABLE TUBING SET

K990911 is an FDA 510(k) clearance for MTP ARTHROPUMP DISPOSABLE TUBING SET, manufactured by Mtp Medical Technical Promotion GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K990911 · Mtp Medical Technical Promotion GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
77d
Days
Class 2
Risk

K990911 is an FDA 510(k) clearance for the MTP ARTHROPUMP DISPOSABLE TUBING SET. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Mtp Medical Technical Promotion GmbH (Culver City, US). The FDA issued a Cleared decision on June 3, 1999 after a review of 77 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 Mtp Medical Technical Promotion GmbH devices

FDA 510(k) Submission Details - K990911

510(k) Number K990911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date June 03, 1999
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K990911.
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · Endius, Inc. · Aug 1999
RIWO DRIVE GENERATOR
K984304 · Richard Wolf Medical Instruments Corp. · Aug 1999
E9000 SYSTEM
K990524 · Linvatec Corp. · Jul 1999
KSEA EPIDUROSCOPE
K991051 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · Electro-Biology, Inc. · Apr 1999
ABLATOR ELECTRODE
K983652 · Linvatec Corp. · Mar 1999