Cleared Traditional

K946174 - BLOCK(TM) ARTHROSCOPIC TOOL KIT

K946174 is an FDA 510(k) clearance for BLOCK(TM) ARTHROSCOPIC TOOL KIT, manufactured by Johnson. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K946174 · Johnson · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
269d
Days
Class 2
Risk

K946174 is an FDA 510(k) clearance for the BLOCK(TM) ARTHROSCOPIC TOOL KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Johnson (Milford, US). The FDA issued a Cleared decision on September 14, 1995 after a review of 269 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson devices

FDA 510(k) Submission Details - K946174

510(k) Number K946174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date September 14, 1995
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 568
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K946174.
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · Richard Wolf Medical Instruments Corp. · Sep 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
K930191 · Sofamor Danek Mfg., Inc. · Sep 1995
DYONICS DISPOSABLE ARTHROSCOPIC BLADES
K953695 · Smith & Nephew Dyonics, Inc. · Sep 1995
PRESSURE SENSING SCOPE SHEATH SYSTEM
K944553 · Linvatec Corp. · Sep 1995
DISPOSABLE BIOPSY FORCEP
K952630 · Neuro Navigational Corp. · Sep 1995
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · Neuro Navigational Corp. · Sep 1995