510(k) Report

510(k) · Cleared

Cleared

Self Retaining Soft Tissue Retractor

K101609510(k) TraditionalCleared Dec 9, 2010184-day reviewClass I21 CFR 888.4540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Koros USA, Inc. · LXH Orthopedic Manual Surgical Instrument

Cleared on Dec 9, 2010 after a 184-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Dec 9, 2010
Review
184 days
Class
Class I
Product code
LXH
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K101609Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LXH devices

LXH Orthopedic Manual Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LXH

1in 2019

2010: 12014: 12019: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXH

Too few LXH 510(k)s in any year since 2007 to give a median.

Recalls per year · LXH

3in 2024

2007: 412008: 412009: 252010: 542011: 122012: 292013: 172014: 122015: 72016: 92017: 142018: 232019: 102020: 32021: 22022: 42023: 42024: 32026 (partial year): 8
2007high 54 (2010) · low 0 (2025)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXH

6,119in 2025

2007: 3982008: 8332009: 1,5692010: 2,3292011: 2,4882012: 2,0592013: 4,1492014: 3,8442015: 5,9442016: 6,3652017: 4,1332018: 4,6852019: 5,2242020: 4,7662021: 4,8322022: 4,8442023: 5,1632024: 6,3192025: 6,119
2007high 6,365 (2016) · low 398 (2007)2025

MAUDE reports naming product code LXH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—41398
20080—41833
20090—251,569
20101—542,329
20110—122,488
20120—292,059
20130—174,149
20141—123,844
20150—75,944
20160—96,365
20170—144,133
20180—234,685
20191—105,224
20200—34,766
20210—24,832
20220—44,844
20230—45,163
20240—36,319
20250—06,119
20260—8—

What is it indicated for?

Device is intended for use in surgical Procedures to provide surgical access to the spine by placing the retractor in incision Prepared by the surgeon down towards the larnina.

Indications for use as stated in the FDA 510(k) statement.

More from Koros USA, Inc.

4 FDA decisions under this applicant name. See the company

  • K120590Dilator Tube SetKoros USA, Inc. · 2013
  • K082399Pectus StrutKoros USA, Inc. · 2009
  • K071338Flex Arm Retractor SystemKoros USA, Inc. · 2007

Recent decisions in LXH

The LXH category page

  • K192873SX-One MicroKnifeSonex Health, Inc. · 20191 recall
  • K140414Imbibe NeedleOrthovita, Inc. · 20141 recall
  • K001507Microperforation InstrumentSmith & Nephew, Inc. · 2000
  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K943873Orthomet Anatomically Guided Carpal Tunnel Release SYOrthomet, Inc. · 1995

https://510kreport.com/device/K101609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101609: Self Retaining Soft Tissue Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101609

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026