510(k) Report

510(k) · Cleared

Cleared

Theken VU Mesh VBR System

K070381510(k) TraditionalCleared Apr 25, 200776-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 Spine, LLC · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 25, 2007 as substantially equivalent to K050058 (Theken Surgical,Llc, 2005) and 5 other predicates after a 76-day review. Its family tree reaches back 7 generations to 1984. 25 later devices descend from it.

Decided
Apr 25, 2007
Review
76 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
6

Its longest line of descent runs back 7 generations to K841189 (1984). 14 ancestors in all. 25 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2001: 4 other ancestors2000: 1 other ancestor2007: 1 descendant cleared2012: 1 descendant cleared2017: 4 descendants cleared2026: 4 descendants cleared2008: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2020: 4 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant 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 · 2004K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005K041888 · 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
  1. Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 1 generation backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
  8. This deviceK070381 Theken VU Mesh VBR SystemTheken Spine, LLC · 2007
  9. Descendant · cites it directly · 18 of its ownK111294 Santorini Spinal SystemK2m, Inc. · 2012
  10. Descendant · 2 generations on · 12 of its ownK142016 CAPRIK2m, Inc. · 2014
  11. Descendant · 2 generations on · 11 of its ownK170055 CAPRI Corpectomy Cage SystemK2m · 2017
  12. Descendant · 2 generations on · 10 of its ownK171704 CAPRI Corpectomy Cage SystemK2m · 2017
  13. Descendant · 3 generations on · 9 of its ownK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12012: 12014: 12015: 12017: 42018: 12019: 12020: 42022: 12023: 32024: 12025: 12026: 4
2007high 4 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 25 · See all
  • K111294Santorini Spinal SystemK2m, Inc. · 2012 · cites it directly18descendants
  • K142016CAPRIK2m, Inc. · 2014 · 2 generations on12descendants
  • K170055CAPRI Corpectomy Cage SystemK2m · 2017 · 2 generations on11descendants
  • K171704CAPRI Corpectomy Cage SystemK2m · 2017 · 2 generations on10descendants
  • K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−6K990148Stackable Cage SystemDepuy Motech Acromed1999—
−5K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−4K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−3K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−2K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005—
0 (this device)K070381Theken VU Mesh VBR SystemTheken Spine, LLC2007—
+1K111294Santorini Spinal SystemK2m, Inc.2012—
+2K142016CAPRIK2m, Inc.2014—
+2K170055CAPRI Corpectomy Cage SystemK2m2017—
+2K171704CAPRI Corpectomy Cage SystemK2m2017—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200140
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201210
201410
201510
201740
201810
201910
202040
202210
202330
202410
202510
202640
FIG. 1 — Lineage of K070381, 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.

Planning a device in MQP? 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
*K050058Theken Reveal VBR System
Summary page 1
…21 CFR 888.3060) Panel: Orthopedic, Product Code: MOP, Panel Code: 87 Predicate Device: Thelken Surgical LLC Reveal VBR System (K050058) Comparative Devices: DePuy-AcroMed, Inc.-Surgical Titanium Mesh System (K003043)…
Theken Surgical,Llc2005—
*K003043Surgical Titanium Mesh System
Summary page 1
…Thelken Surgical LLC Reveal VBR System (K050058) Comparative Devices: DePuy-AcroMed, Inc.-Surgical Titanium Mesh System (K003043) Synthes (USA)- SynMesh Spacer System (K003275) Encore Orthopedics, I…
Depuyacromed2001—
*K003275Synthes Synmesh Spacer System
Summary page 1
…s: DePuy-AcroMed, Inc.-Surgical Titanium Mesh System (K003043) Synthes (USA)- SynMesh Spacer System (K003275) Encore Orthopedics, Inc.-Titanium Mesh (K032371) SIGNUS Medical LILC…
Synthes (Usa)200114
*K032371Titanium Mesh System
Summary page 1
…(K003043) Synthes (USA)- SynMesh Spacer System (K003275) Encore Orthopedics, Inc.-Titanium Mesh (K032371) SIGNUS Medical LILC -Curved PEEK TetriSTM (K041888) SIGNUS Medical L…
Encore Medical L.P.2004—
*K041888Curved Peek Tetris Spinal Implant
Summary page 1
…System (K003275) Encore Orthopedics, Inc.-Titanium Mesh (K032371) SIGNUS Medical LILC -Curved PEEK TetriSTM (K041888) SIGNUS Medical LLC - PEEK TetriSTiM (K031757) Material Composition: PolyEtherEtherKetone (…
Signus Medizintechnik GmbH2004—
*K031757Peek Tetris Spinal Implant
Summary page 1
…anium Mesh (K032371) SIGNUS Medical LILC -Curved PEEK TetriSTM (K041888) SIGNUS Medical LLC - PEEK TetriSTiM (K031757) Material Composition: PolyEtherEtherKetone (PEEK OPTIMA LT) per ASTM F2026.…
Signus Medical, LLC2003—

Also cleared against K050058: 6 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K111294Santorini Spinal SystemK2m, Inc.201218
K172323Omnia Medical VBROmnia Medical, LLC20176
K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260

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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • Of its descendants, K111294 (K2m, Inc., 2012) has gone furthest, with 18 descendants of its own.
  • 6 other devices also cite its predicate K050058.

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. 2007, this device’s year, is highlighted.

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 MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (Ti -L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture). The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of…

Read the full statement (118 words)

The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (Ti -L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

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

The Theken VU MESH VBR SYSTEM is intended for use 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 K050058

6 other devices cite the same predicate.

  • K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
  • K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
  • K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
  • K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 20081 recall
  • K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
  • K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC · 2007

More from Theken Spine, LLC

23 FDA decisions under this applicant name. See the company

  • K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
  • K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2012
  • K120829Stainless Steel Spinal SystemTheken Spine, LLC · 2012
  • K120047Coral Spinal SystemTheken Spine, LLC · 2012
  • K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011

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/K070381 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070381: Theken VU Mesh 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/K070381

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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