Cleared Traditional

K051827 - JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE

K051827 is an FDA 510(k) clearance for JOIMAX ENDOSCOPE/MULTISCOPE, manufactured by Joimax GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K051827 · Joimax GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
37d
Days
Class 2
Risk

K051827 is an FDA 510(k) clearance for the JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINO.... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Joimax GmbH (Los Gatos, US). The FDA issued a Cleared decision on August 12, 2005 after a review of 37 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.

FDA 510(k) Submission Details - K051827

510(k) Number K051827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2005
Decision Date August 12, 2005
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRX Arthroscope

All 672
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K051827.
DISC-FX SYSTEM
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K051656 · Osteobiologics, Inc. · Oct 2005
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SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · Smith & Nephew Endoscopy, Inc. · Apr 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · Medtronic Sofamor Danek · Jan 2005
K051827 · JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE
Download PDF FDA Summary Joimax GmbH