Cleared Traditional

K101609 - SELF RETAINING SOFT TISSUE RETRACTOR

K101609 is an FDA 510(k) clearance for SELF RETAINING SOFT TISSUE RETRACTOR, manufactured by Koros USA, Inc.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K101609 · Koros USA, Inc. · Orthopedic device
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Dec 2010
Decision
184d
Days
Class 1
Risk

K101609 is an FDA 510(k) clearance for the SELF RETAINING SOFT TISSUE RETRACTOR. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Koros USA, Inc. (Moorepark, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 184 days - an extended review 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: 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 Koros USA, Inc. devices

FDA 510(k) Submission Details - K101609

510(k) Number K101609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2010
Decision Date December 09, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 122d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
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 - LXH Orthopedic Manual Surgical Instrument

All 27
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K101609.
SX-One MicroKnife
K192873 · Sonex Health, Inc. · Dec 2019
IMBIBE NEEDLE
K140414 · Orthovita, Inc. · Apr 2014
MICROPERFORATION INSTRUMENT
K001507 · Smith & Nephew, Inc. · Jun 2000
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
K952495 · Orthopedic Systems, Inc. · Jan 1996
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873 · Orthomet, Inc. · Apr 1995
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
K941896 · Depuy, Inc. · Nov 1994