510(k) Report

510(k) · Cleared

Cleared

Theken Reveal VBR System

K050058510(k) TraditionalCleared May 17, 2005126-day reviewClass II21 CFR 888.3060

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

Theken Surgical,Llc · MQP Spinal Vertebral Body Replacement Device

Cleared on May 17, 2005 as substantially equivalent to K032064 (Theken Surgical,Llc, 2004) and 5 other predicates after a 126-day review. Its family tree reaches back 6 generations to 1984. 1 of the 738 devices in its family, counting itself, has a Class I recall. 727 later devices descend from it.

Decided
May 17, 2005
Review
126 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K841189 (1984). 10 ancestors in all. 727 later devices descend from it, 7 citing it directly. 1 of the 738 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor2019: 59 descendants cleared2007: 4 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2017: 43 descendants cleared2012: 3 descendants cleared2026: 62 descendants cleared2010: 2 descendants cleared2013: 5 descendants cleared2018: 44 descendants cleared2011: 3 descendants cleared2022: 68 descendants cleared2014: 8 descendants cleared2020: 79 descendants cleared2023: 80 descendants cleared2021: 59 descendants cleared, 1 with a Class I recall12016: 32 descendants cleared2015: 13 descendants cleared2025: 74 descendants cleared2024: 86 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 21 descendants3 generations forward: 45 descendants4 generations forward: 61 descendants5 generations forward: 91 descendants6 generations forward: 134 descendants7 generations forward: 155 descendants, 1 with a Class I recall18 generations forward: 126 descendants9 generations forward: 52 descendants10 generations forward: 24 descendants11 generations forward: 10 descendants12 generations forward: 1 descendant K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50+5+10
  1. Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 1 generation backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. This deviceK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  8. Descendant · cites it directly · 708 of its ownK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
  9. Descendant · 2 generations on · 601 of its ownK112359 Prow FusionNlt Spine, Ltd. · 2011
  10. Descendant · 3 generations on · 593 of its ownK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
  11. Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
  12. Descendant · 2 generations on · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010

Showing 5 of 727 descendants. See all descendants

Descendants cleared per year

2007: 42008: 22009: 12010: 22011: 32012: 32013: 52014: 82015: 132016: 322017: 432018: 442019: 592020: 792021: 592022: 682023: 802024: 862025: 742026: 62
2007high 86 (2024) · low 1 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 727 · See all
  • K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · cites it directly708descendants
  • K112359Prow FusionNlt Spine, Ltd. · 2011 · 2 generations on601descendants
  • K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013 · 3 generations on593descendants
  • K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
  • K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · 2 generations on480descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−5K990148Stackable Cage SystemDepuy Motech Acromed1999—
−4K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−3K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−2K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−1K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
0 (this device)K050058Theken Reveal VBR SystemTheken Surgical,Llc2005—
+1K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20081
+2K112359Prow FusionNlt Spine, Ltd.2011—
+3K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200740
200820
200910
201020
201130
201230
201350
201480
2015130
2016320
2017430
2018440
2019590
2020790
2021591
2022680
2023800
2024860
2025740
2026620
FIG. 1 — Lineage of K050058, 1984–2026Source: 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? (6)

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
*K032064Theken Cpod/Lpod Vertebral Body Replacement System
Summary page 1
…CER 888.3060) Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Predicate Device: Theken Surgical LLC CPOD/LPOD VBR System (K032064) Comparative Devices: SIGNUS Medical LLC TetrisT Spinal Implant (K022793) Synthes Spine Co…
Theken Surgical,Llc20041
*K022793Tetris Spinal Implant
Summary page 1
…Panel Code: 87 Predicate Device: Theken Surgical LLC CPOD/LPOD VBR System (K032064) Comparative Devices: SIGNUS Medical LLC TetrisT Spinal Implant (K022793) Synthes Spine Company, LI.P Synthes Syne XTM Spacer System (K0…
Signus Medical, LLC2003—
*K003836Synthes Synex Spacer System
Summary page 1
…edical LLC TetrisT Spinal Implant (K022793) Synthes Spine Company, LI.P Synthes Syne XTM Spacer System (K003836) Osteotech Inc., VBR TM (K003155)…
Synthes200111
*K003155Vertebral Body Replacement
Summary page 1
…Synthes Spine Company, LI.P Synthes Syne XTM Spacer System (K003836) Osteotech Inc., VBR TM (K003155) TM DePuy AcroMed, Inc. Stacka…
Osteotech, Inc.2001—
*K990148Stackable Cage System
Summary page 1
…VBR TM (K003155) TM DePuy AcroMed, Inc. Stackable Cage System (K990 148) TM SIGNUS Medical LLC…
Depuy Motech Acromed1999—
*K041888Curved Peek Tetris Spinal Implant
Summary page 1
…K990 148) TM SIGNUS Medical LLC Curved PEEK TetriS (K041888) Material Composition: Polyetheretherketone (PEEK OPTIMA LT) per ASTM F2026. Subject Device Description: The Theken VU…
Signus Medizintechnik GmbH2004—

Also cleared against K032064: 7 other devices →

What descends from it? (727)

See all 727

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

NumberDeviceApplicantDecidedDescendants
K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC2008708
K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119
K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118
K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761
K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960
K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725
K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070

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

No FDA recall names this device.

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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K080822 (Theken Spine, LLC, 2008) has gone furthest, with 708 descendants of its own.
  • 7 other devices also cite its predicate K032064.

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 Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device…

Read the full statement (115 words)

The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken VU VBR SYSTEM is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

Indications for use as stated in the FDA summary.

Also cleared against K032064

7 other devices cite the same predicate.

  • K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
  • K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
  • K072326Ostapek VBR SystemCo-Ligne AG · 2008
  • K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
  • K062151Box Peek VBR SystemInnovasis, Inc. · 2006
  • K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc. · 2005

More from Theken Surgical,Llc

6 FDA decisions under this applicant name. See the company

  • K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc · 20041 recall
  • K012462Theken Large Cement RestrictorTheken Surgical,Llc · 2001
  • K012278Theken Small Cement RestrictorTheken Surgical,Llc · 2001
  • K010466Tether AcfsTheken Surgical,Llc · 2001
  • K983622Bodyform Thoraco-Lumbar Fixation SystemTheken Surgical,Llc · 1998

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/K050058 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050058: Theken Reveal VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050058

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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