Cleared Traditional

K943943 - TRANSTIBIAL ACL DISPOSABLES KIT

K943943 is the FDA 510(k) clearance for TRANSTIBIAL ACL DISPOSABLES KIT by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K943943 · Arthrex, Inc. · Orthopedic device
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Dec 1994
Decision
131d
Days
Class 2
Risk

K943943 is an FDA 510(k) clearance for the TRANSTIBIAL ACL DISPOSABLES KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 20, 1994 after a review of 131 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 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 Arthrex, Inc. devices

Submission Details

510(k) Number K943943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1994
Decision Date December 20, 1994
Days to Decision 131 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K943943.
ARTHROSCOPE ACCESSORIES
K944210 · Stryker Endoscopy · Feb 1995
CTS RELIEF KIT
K941651 · Linvatec Corp. · Jan 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES
K943323 · Stryker Corp. · Nov 1994
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · Richard Wolf Medical Instruments Corp. · Nov 1994