510(k) · Cleared

Cleared

Hydrofix Surgical Sheet

K100905510(k) SpecialCleared Jun 2, 201062-day reviewClass II21 CFR 870.3470

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

Mimedx Group, Inc. · OMR Vessel Guard Or Cover

Cleared on Jun 2, 2010 as substantially equivalent to K090022 (Spinemedica, LLC, 2009) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.

Decided: Jun 2, 2010
Review: 62 days
Class: Class II
Product code: OMR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K090022 (2009). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK090022 Paradis Vaso ShieldSpinemedica, LLC · 2009
This deviceK100905 Hydrofix Surgical SheetMimedx Group, Inc. · 2010
Descendant · cites it directly · 0 of its ownK101805 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090022	Paradis Vaso Shield	Spinemedica, LLC	2009	—
0 (this device)	K100905	Hydrofix Surgical Sheet	Mimedx Group, Inc.	2010	—
+1	K101805	Hydrofix Vaso Shield	Mimedx Group, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K100905, 2009–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in OMR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K090022	Paradis Vaso Shield Summary page 2 …May 5, 201 0 Substantially Equivalent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 Farad/s Vaso ShieldTM K093551 Paradis Vaso ShieldTM The MiMedx HydroFiXTM Vaso Shield was shown to be substantially equivalent to…	Spinemedica, LLC	2009	—
*	K093551	Paradis Vaso Shield Summary page 2 …May 5, 201 0 Substantially Equivalent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 Farad/s Vaso ShieldTM K093551 Paradis Vaso ShieldTM The MiMedx HydroFiXTM Vaso Shield was shown to be substantially equivalent to previously cleared device and…	Spinemedica, LLC	2009	—

Also cleared against K090022: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101805	Hydrofix Vaso Shield	Mimedx Group, Inc.	2011	0

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.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K101805 (Mimedx Group, Inc., 2011) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K090022.

How does its category compare?

All OMR devices

OMR Vessel Guard Or Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OMR

1in 2012

2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMR

78in 2011

2007high 105 (2009) · low 62 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OMR

No recall names OMR since 2007.

Adverse event reports per year · OMR

1in 2013

2007high 1 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	3	105	0
2010	3	62	0
2011	3	78	0
2012	1	—	0
2013	0	—	1
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The MiMedx Group, Inc. HydroFixTM Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100905 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100905: Hydrofix Surgical Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100905

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026