Cleared Traditional

K885311 - MENISCUS MENDER II LOOP

K885311 is an FDA 510(k) clearance for MENISCUS MENDER II LOOP, manufactured by Instrument Makar, Inc.. The device is a Class 1 Orthopedic device with product code HWQ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K885311 · Instrument Makar, Inc. · Orthopedic device
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Feb 1989
Decision
42d
Days
Class 1
Risk

K885311 is an FDA 510(k) clearance for the MENISCUS MENDER II LOOP. Classified as Passer (product code HWQ), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on February 9, 1989 after a review of 42 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 Instrument Makar, Inc. devices

FDA 510(k) Submission Details - K885311

510(k) Number K885311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1988
Decision Date February 09, 1989
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

HWQ Device Classification - Class 1, General Controls

Product Code HWQ Passer
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 - HWQ Passer

Devices cleared under the same product code (HWQ) and FDA review panel - the closest regulatory comparables to K885311.
MITEK SUTURE RETROGRADER
K970360 · Mitek Products · Mar 1997
ACUFEX PASSING PINS AND SURGICAL WIRE
K920621 · Acufex Microsurgical, Inc. · May 1993
SOFT TISSUE EXPANDER
K923381 · Acufex Microsurgical, Inc. · May 1993
VICO MICRO SURGICAL INSTRUMENTS
K843592 · Visitec Co. · Oct 1984
SILASTIC TENDON PASSER H.P.
K811679 · Dow Corning Corp. Healthcare Industries Materials · Jul 1981
ROTH-KENNEDY PASSER
K791960 · 3M Company · Oct 1979