Cleared Traditional

K873713 - TRIANGULAR KNIFE

K873713 is an FDA 510(k) clearance for TRIANGULAR KNIFE, manufactured by Arthropedics, Inc.. The device is a Class 1 Orthopedic device with product code HTS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K873713 · Arthropedics, Inc. · Orthopedic device
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Nov 1987
Decision
48d
Days
Class 1
Risk

K873713 is an FDA 510(k) clearance for the TRIANGULAR KNIFE, DISPOSABLE #TM-1611. Classified as Knife, Orthopedic (product code HTS), Class I - General Controls.

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 2, 1987 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Arthropedics, Inc. devices

FDA 510(k) Submission Details - K873713

510(k) Number K873713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date November 02, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

HTS Device Classification - Class 1, General Controls

Product Code HTS Knife, Orthopedic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HTS Knife, Orthopedic

Devices cleared under the same product code (HTS) and FDA review panel - the closest regulatory comparables to K873713.
CUSTOM ORTHOPAEDIC TRAYS (PACKS)
K930507 · Associated Medical Products Co. · Feb 1994
ACUFLEX DISPOSABLE KNIVES
K933921 · Acufex Microsurgical, Inc. · Jan 1994
RETROGRADE KNIFE, DISPOSABLE #TM-1613
K873711 · Arthropedics, Inc. · Nov 1987
BANANA KNIFE, DISPOSABLE #TM-1612
K873714 · Arthropedics, Inc. · Nov 1987
STANDARD KNIFE, DISPOSABLE #TM-1610
K873712 · Arthropedics, Inc. · Oct 1987
ARTHROSCOPE OPERATIVE KNIFE SET
K771851 · Richard Wolf Medical Instruments Corp. · Oct 1977