510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Endoskeleton TA Vertebral Body Replacement

K032812510(k) TraditionalCleared Dec 8, 200390-day reviewClass II21 CFR 888.3060Recalls 1

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

Orthovita, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Dec 8, 2003 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2001. 1 of the 573 devices in its family, counting itself, has a Class I recall. 565 later devices descend from it. It has been recalled once.

Decided
Dec 8, 2003
Review
90 days
Class
Class II
Product code
MQP
Recalls
1
Predicates
4

Its longest line of descent runs back 3 generations to K003275 (2001). 7 ancestors in all, the oldest K841189 (1984). 565 later devices descend from it, 4 citing it directly. 1 of the 573 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor2000: 1 other ancestor1984: 1 other ancestor2014: 7 descendants cleared2008: 1 descendant cleared2020: 58 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2017: 19 descendants cleared2019: 38 descendants cleared2015: 6 descendants cleared2016: 14 descendants cleared2018: 28 descendants cleared2013: 1 descendant cleared2021: 51 descendants cleared, 1 with a Class I recall12012: 1 descendant cleared2022: 61 descendants cleared2024: 83 descendants cleared2023: 68 descendants cleared2026: 58 descendants cleared2025: 67 descendants clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 13 descendants3 generations forward: 37 descendants4 generations forward: 83 descendants5 generations forward: 122 descendants6 generations forward: 105 descendants7 generations forward: 97 descendants, 1 with a Class I recall18 generations forward: 70 descendants9 generations forward: 21 descendants10 generations forward: 8 descendants11 generations forward: 4 descendants12 generations forward: 1 descendant K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled0+5+10
  1. Root · 3 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 2 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 1 generation backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. This deviceK032812 Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc. · 2003
  5. Descendant · cites it directly · 564 of its ownK080615 Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC · 2008
  6. Descendant · 2 generations on · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
  7. Descendant · 3 generations on · 460 of its ownK133286 Midline (TM)Centinel Spine, Inc. · 2014
  8. Descendant · 3 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
  9. Descendant · 2 generations on · 412 of its ownK083714 Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009

Showing 5 of 565 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22011: 12012: 12013: 12014: 72015: 62016: 142017: 192018: 282019: 382020: 582021: 512022: 612023: 682024: 832025: 672026: 58
2008high 83 (2024) · low 1 (2008)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 565 · See all
  • K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC · 2008 · cites it directly564descendants
  • K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · 2 generations on480descendants
  • K133286Midline (TM)Centinel Spine, Inc. · 2014 · 3 generations on460descendants
  • K141942Midline II TICentinel Spine, Inc. · 2014 · 3 generations on459descendants
  • K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009 · 2 generations on412descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−2K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−1K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
0 (this device)K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.2003—
+1K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010—
+3K133286Midline (TM)Centinel Spine, Inc.2014—
+3K141942Midline II TICentinel Spine, Inc.2014—
+2K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201110
201210
201310
201470
201560
2016140
2017190
2018280
2019380
2020580
2021511
2022610
2023680
2024830
2025670
2026580
FIG. 1 — Lineage of K032812, 2001–2026Source: 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K990148Stackable Cage System
Summary page 1
…ent Common or Usual Name Vertebral Body Replacement Classification Name Vertebral Body Replacement (MQP) Predicate Devices * DePuy Acromed Stackable Cage (K990 148, K013382) * Synthes Vertebral Spacer Ti (K020152, K024364) Intended Use The Endoskeleton TA VBR is for us…
Depuy Motech Acromed1999—
*K013382Modification to: Stackable Cage System
Summary page 1
…on or Usual Name Vertebral Body Replacement Classification Name Vertebral Body Replacement (MQP) Predicate Devices * DePuy Acromed Stackable Cage (K990 148, K013382) * Synthes Vertebral Spacer Ti (K020152, K024364) Intended Use The Endoskeleton TA VBR is for use in the…
Depuyacromed2001—
*K020152Synthes Vertebral Spacer TI
Summary page 1
…assification Name Vertebral Body Replacement (MQP) Predicate Devices * DePuy Acromed Stackable Cage (K990 148, K013382) * Synthes Vertebral Spacer Ti (K020152, K024364) Intended Use The Endoskeleton TA VBR is for use in the thoracolumbar spine (Ti- L5) to replace all or p…
Synthes (Usa)2002—
*K024364Synthes Vertebral Spacer TI (Curved and Narrow)
Summary page 1
…ion Name Vertebral Body Replacement (MQP) Predicate Devices * DePuy Acromed Stackable Cage (K990 148, K013382) * Synthes Vertebral Spacer Ti (K020152, K024364) Intended Use The Endoskeleton TA VBR is for use in the thoracolumbar spine (Ti- L5) to replace all or part of a…
Synthes (Usa)2003—

Also cleared against K990148: 20 other devices →

What descends from it? (565)

See all 565

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

NumberDeviceApplicantDecidedDescendants
K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564
K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267
K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC2014265
K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 19, 2012Class IIZ-0535-2013Labeling False and MisleadingTitan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 11 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K080615 (Titan Spine, LLC, 2008) has gone furthest, with 564 descendants of its own.
  • 20 other devices also cite its predicate K990148.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Endoskeleton TA VBR is for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Endoskeleton TA VBR is intended for use with supplemental internal spinal fixation systems. The Endoskeleton TA VBR may be used with bone graft material or bone graft substitute.

Indications for use as stated in the FDA summary.

Also cleared against K990148

20 other devices cite the same predicate.

  • K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh…Medos International SARL · 2018
  • K092774Atlas Intervertebral Body CageSpinal Edge, LLC · 2010
  • K090566Pathway AvidCustom Spine, Inc. · 2009
  • K080281PathwayCustom Spine, Inc. · 2008
  • K073649Bengal Stackable Cage SystemDepuy Spine, Inc. · 2008
  • K061752Spinal Usa VBR SystemSpinal USA · 2006

More from Orthovita, Inc.

23 FDA decisions under this applicant name. See the company

  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
  • K161447HydroSet XTOrthovita, Inc. · 20162 recalls
  • K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
  • K153306Imbibe NeedleOrthovita, Inc. · 2015
  • K140868Stryker Kwic NeedleOrthovita, Inc. · 2014

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K032812 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032812: Endoskeleton TA Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032812

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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