Cleared Traditional

K946313 - TIBIAL ROUTERS

K946313 is an FDA 510(k) clearance for TIBIAL ROUTERS, manufactured by Smith and Nephew Donjoy, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K946313 · Smith and Nephew Donjoy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
79d
Days
Class 2
Risk

K946313 is an FDA 510(k) clearance for the TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith and Nephew Donjoy, Inc. (Carsbad, US). The FDA issued a Cleared decision on March 17, 1995 after a review of 79 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 Smith and Nephew Donjoy, Inc. devices

FDA 510(k) Submission Details - K946313

510(k) Number K946313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date March 17, 1995
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 416
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K946313.
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ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K943450 · Arthrocare Corp. · Mar 1995
ARTHROSCOPE ACCESSORIES
K944210 · Stryker Endoscopy · Feb 1995
CTS RELIEF KIT
K941651 · Linvatec Corp. · Jan 1995