510(k) Report

510(k) · Cleared

Cleared

Biotrace, Model 1730

K002063510(k) TraditionalCleared Aug 10, 200034-day reviewClass II21 CFR 882.5300

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

Bryan Corp. · MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Cleared on Aug 10, 2000 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Aug 10, 2000
Review
34 days
Class
Class II
Product code
MYU
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2005: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK002063 Biotrace, Model 1730Bryan Corp. · 2000
  2. Descendant · cites it directly · 4 of its ownK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
  3. Descendant · 2 generations on · 2 of its ownK051821 Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
  4. Descendant · 2 generations on · 1 of its ownK071810 Inion Spinal Graft Containment SystemInion, Ltd. · 2008
  5. Descendant · 3 generations on · 0 of its ownK151360 Inion Spinal Graft Containment SystemInion OY · 2015
  6. Descendant · 2 generations on · 0 of its ownK063461 Anova Containment DeviceAnova Corporation · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12008: 12009: 12015: 1
2003high 1 (2003) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004 · cites it directly4descendants
  • K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005 · 2 generations on2descendants
  • K071810Inion Spinal Graft Containment SystemInion, Ltd. · 2008 · 2 generations on1descendant
  • K151360Inion Spinal Graft Containment SystemInion OY · 2015 · 3 generations on0descendants
  • K063461Anova Containment DeviceAnova Corporation · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002063Biotrace, Model 1730Bryan Corp.2000—
+1K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.2004—
+2K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd.2005—
+2K071810Inion Spinal Graft Containment SystemInion, Ltd.2008—
+3K151360Inion Spinal Graft Containment SystemInion OY2015—
+2K063461Anova Containment DeviceAnova Corporation2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200810
200910
201510
FIG. 1 — Lineage of K002063, 2000–2015Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MYU? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc.20044
K024359Vista Scientific Barium Sulfate, Model 3001-1Vista Scientific, LLC20030

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, K041105 (Macropore Biosurgery, Inc., 2004) has gone furthest, with 4 descendants of its own.

How does its category compare?

All MYU devices

MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MYU

FDA has decided no MYU device since 2007.

Median 510(k) review, days · MYU

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

Recalls per year · MYU

No recall names MYU since 2007.

Adverse event reports per year · MYU

No MAUDE report names MYU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
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—

More from Bryan Corp.

5 FDA decisions under this applicant name. See the company

  • K913242Microprocessed Controlled LaparoflatorBryan Corp. · 1992
  • K894380Dumon Tracheobronchial StentBryan Corp. · 1989
  • K881249Baggish, HysteroscopeBryan Corp. · 1988
  • K854414Dumon/HarrellBryan Corp. · 1986

Recent decisions in MYU

The MYU category page

  • K033230Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003
  • K032388Bone Cement Radio-OpacifierCardinalhealth · 2003
  • K024359Vista Scientific Barium Sulfate, Model 3001-1Vista Scientific, LLC · 2003
  • K023445Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003
  • K991893Parallax Tracer Radiopaque ParticlesParallax Medical, Inc. · 1999

https://510kreport.com/device/K002063 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002063: Biotrace, Model 1730.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002063

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026