510(k) Report

510(k) · Decided

Decided

Paradis Vaso Shield

K093551510(k) SpecialDecided Dec 24, 200937-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

Spinemedica, LLC · OMR Vessel Guard Or Cover

Cleared on Dec 24, 2009 after a 37-day review. The FDA summary names no predicate by number. 4 later devices descend from it.

Decided
Dec 24, 2009
Review
37 days
Class
Class II
Product code
OMR
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared20052010201520202025
  1. This deviceK093551 Paradis Vaso ShieldSpinemedica, LLC · 2009
  2. Descendant · cites it directly · 1 of its ownK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
  3. Descendant · cites it directly · 1 of its ownK100905 Hydrofix Surgical SheetMimedx Group, Inc. · 2010
  4. Descendant · 2 generations on · 0 of its ownK111048 Synthes Scout Tack FixationSynthes Spine · 2012
  5. Descendant · cites it directly · 0 of its ownK101805 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011

Most influential descendants

Showing 4 of 4 · See all
  • K103558Synthes Scout Vessel GuardSynthes Spine · 2011 · cites it directly1descendant
  • K100905Hydrofix Surgical SheetMimedx Group, Inc. · 2010 · cites it directly1descendant
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012 · 2 generations on0descendants
  • K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K093551Paradis Vaso ShieldSpinemedica, LLC2009—
+1K103558Synthes Scout Vessel GuardSynthes Spine2011—
+1K100905Hydrofix Surgical SheetMimedx Group, Inc.2010—
+2K111048Synthes Scout Tack FixationSynthes Spine2012—
+1K101805Hydrofix Vaso ShieldMimedx Group, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201210
FIG. 1 — Lineage of K093551, 2009–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103558Synthes Scout Vessel GuardSynthes Spine20111
K100905Hydrofix Surgical SheetMimedx Group, Inc.20101
K101805Hydrofix Vaso ShieldMimedx Group, Inc.20110

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?

  • Of its descendants, K103558 (Synthes Spine, 2011) has gone furthest, with 1 descendant of its own.

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. 2009, this device’s year, is highlighted.

FDA decisions per year · OMR

1in 2012

2009: 32010: 32011: 32012: 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMR

78in 2011

2009: 105 days median2010: 62 days median2011: 78 days median
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

2013: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
2009310500
201036200
201137800
20121—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The SpineMedica Paradis Vaso ShieldTM is indicated as a cover for vessels following anterior vertebral surgery.

Indications for use as stated in the FDA summary.

More from Spinemedica, LLC

2 FDA decisions under this applicant name. See the company

  • K090022Paradis Vaso ShieldSpinemedica, LLC · 2009

Recent decisions in OMR

The OMR category page

  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K111137Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K103558Synthes Scout Vessel GuardSynthes Spine · 2011
  • K101826Hydrofix Vaso Shield, Model HVS-001-0610Mimedx Group, Inc. · 2010

https://510kreport.com/device/K093551 · printed Nov 5, 2026

Cite this page

510(k) Report. “K093551: Paradis Vaso Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093551

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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