Cleared Abbreviated

K090132 - MAXMORESPINE SPINAL SYSTEM

K090132 is an FDA 510(k) clearance for MAXMORESPINE SPINAL SYSTEM, manufactured by Hoogland Spine Products, GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Abbreviated 510(k) pathway after a 139-day FDA review.

K090132 · Hoogland Spine Products, GmbH · Orthopedic device
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Jun 2009
Decision
139d
Days
Class 2
Risk

K090132 is an FDA 510(k) clearance for the MAXMORESPINE SPINAL SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hoogland Spine Products, GmbH (Muenchen, DE). The FDA issued a Cleared decision on June 9, 2009 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hoogland Spine Products, GmbH devices

FDA 510(k) Submission Details - K090132

510(k) Number K090132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date June 09, 2009
Days to Decision 139 days
Submission Type Abbreviated
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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Standards-based clearance path.

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 570
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K090132.
SPINAL FORAMINOSCOPE
K082841 · Blazejewski Medi-Tech GmbH · Sep 2009
ARTHROSCOPE
K091398 · Orthopedic Sciences, Inc. · Aug 2009
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · Arthrex, Inc. · Aug 2009
PERCUTANEOUS DISCECTOMY SYSTEM
K090815 · Laurimed, LLC · May 2009
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
K090303 · Corespine Technologies, LLC · Apr 2009
ENSPIRE DEBRIDER SYSTEM
K090278 · Spine View, Inc. · Apr 2009