510(k) Report

510(k) · Decided

Decided

Synthes Scout Tack Fixation

K111048510(k) TraditionalDecided Jun 14, 2012426-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

Synthes Spine · OMR Vessel Guard Or Cover

Cleared on Jun 14, 2012 as substantially equivalent to K103558 (Synthes Spine, 2011) and 3 other predicates after a 426-day review. Its family tree reaches back 5 generations to 1981.

Decided
Jun 14, 2012
Review
426 days
Class
Class II
Product code
OMR
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K811841 (1981). 28 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 3 other ancestors2004: 1 other ancestor2007: 2 other ancestors1997: 1 other ancestor1996: 5 other ancestors1994: 2 other ancestors1985: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor1986: 2 other ancestors1976: 1 other ancestor1995: 2 other ancestorsK811841 · Gore-Tex Cardiovascular Patch · W. L. Gore & Associates, Inc. · 1981K984526 · Acuseal Cardiovascular Patch · W. L. Gore & Associates, Inc. · 1999K061727 · Gore Preclude Vessel Guard · W. L. Gore & Associates, Inc. · 2006K082782 · Replication Medical Vessel Guard · Replication Medical, Inc. · 2009K103558 · Synthes Scout Vessel Guard · Synthes Spine · 20111980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 8 other ancestors4 generations back: 3 other ancestors K103558 · Synthes Scout Vessel Guard · Synthes Spine · 2011K082782 · Replication Medical Vessel Guard · Replication Medical, Inc. · 2009K061727 · Gore Preclude Vessel Guard · W. L. Gore & Associates, Inc. · 2006K984526 · Acuseal Cardiovascular Patch · W. L. Gore & Associates, Inc. · 1999K811841 · Gore-Tex Cardiovascular Patch · W. L. Gore & Associates, Inc. · 1981−50
  1. Root · 5 generations backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
  2. 4 generations backK984526 Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999
  3. 3 generations backK061727 Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006
  4. 2 generations backK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
  5. 1 generation backK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
  6. This deviceK111048 Synthes Scout Tack FixationSynthes Spine · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K811841Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc.1981—
−4K984526Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc.1999—
−3K061727Gore Preclude Vessel GuardW. L. Gore & Associates, Inc.2006—
−2K082782Replication Medical Vessel GuardReplication Medical, Inc.2009—
−1K103558Synthes Scout Vessel GuardSynthes Spine2011—
0 (this device)K111048Synthes Scout Tack FixationSynthes Spine2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197610
198510
198620
198810
199120
199420
199520
199650
199710
200410
200720
200930
FIG. 1 — Lineage of K111048, 1981–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K103558Synthes Scout Vessel Guard
Summary page 1
…Orthopaedic Devices Panel Product Code: NDM (pin, fixation, threaded, metallic) Predicate Synthes Scout Vessel Guard, K103558 Devices: Synthes Arch Fixation System, K032534 Replication Medical EnGuard Vessel Guard, K08…
Synthes Spine2011—
*K032534Synthes Afs
Summary page 1
…Product Code: NDM (pin, fixation, threaded, metallic) Predicate Synthes Scout Vessel Guard, K103558 Devices: Synthes Arch Fixation System, K032534 Replication Medical EnGuard Vessel Guard, K082782 Covidien Autosuture Tacker System…
Synthes Spine2004—
*K082782Replication Medical Vessel Guard
Summary page 1
…Synthes Scout Vessel Guard, K103558 Devices: Synthes Arch Fixation System, K032534 Replication Medical EnGuard Vessel Guard, K082782 Covidien Autosuture Tacker System, K090470 Device The Synthes Scout Tack Fixation is a met…
Replication Medical, Inc.2009—
*K090470Autosuture Protack; Tacker System; Absorbatack Fixation Devices
Summary page 1
…Synthes Arch Fixation System, K032534 Replication Medical EnGuard Vessel Guard, K082782 Covidien Autosuture Tacker System, K090470 Device The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Description: Guard t…
Covidien20092

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.

What does this lineage say?

  • The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 28 ancestors have a recall of any class.

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. 2012, 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 Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.

Indications for use as stated in the FDA summary.

More from Synthes Spine

36 FDA decisions under this applicant name. See the company

  • K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012
  • K113149Synthes Uss ConnectorsSynthes Spine · 2012

Recent decisions in OMR

The OMR category page

  • 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
  • K100984Xylos Vessel GuardXylos Corporation · 2010

https://510kreport.com/device/K111048 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111048: Synthes Scout Tack Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111048

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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