Cleared Traditional

K940554 - TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS

K940554 is an FDA 510(k) clearance for TNCO, manufactured by Tnco, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K940554 · Tnco, Inc. · Orthopedic device
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Jun 1994
Decision
142d
Days
Class 2
Risk

K940554 is an FDA 510(k) clearance for the TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Tnco, Inc. (Whitman, US). The FDA issued a Cleared decision on June 29, 1994 after a review of 142 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 Tnco, Inc. devices

FDA 510(k) Submission Details - K940554

510(k) Number K940554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 07, 1994
Decision Date June 29, 1994
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 556
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K940554.
REVO ROTATOR CUFF REPAIR SYSTEM
K941691 · Linvatec Corp. · Sep 1994
CARPAL TUNNEL SYSTEM
K940234 · Richard Wolf Medical Instruments Corp. · Aug 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · Smith & Nephew, Inc. · Jun 1994
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · Acufex Microsurgical, Inc. · Jun 1994
ACUMED FLEXIBLE CANNULA
K932099 · Acu Med, Inc. · Jun 1994
ARTHROSCOPE
K940090 · Richard Wolf Medical Instruments Corp. · Jun 1994