510(k) Report

510(k) · Cleared

Cleared

X-Pod Adjustable Vertebral Body Replacement

K070786510(k) TraditionalCleared Jun 28, 200798-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 Jun 28, 2007 as substantially equivalent to K050058 (Theken Surgical,Llc, 2005) and 3 other predicates after a 98-day review. Its family tree reaches back 7 generations to 1984.

Decided
Jun 28, 2007
Review
98 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K841189 (1984). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 3 other ancestors2004: 1 other ancestor2000: 1 other ancestorK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K050058 · Theken Reveal VBR System · Theken Surgical,Llc · 2005198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 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
  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 deviceK070786 X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC · 2007
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)K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200130
200410
FIG. 1 — Lineage of K070786, 1984–2007Source: 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? (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
*K050058Theken Reveal VBR System
Summary page 2
…eristics of the x°POD Adjustable Vertebral Body Replacement are similar to the following predicate devices: REVEAL VBR System manufactured by Theken Spine, LLC (K050058, SE 05/17/05). VBPTM manufactured by Osteotech, Inc (K003155, SE 01/04/2001). VBR rMmanufactured by Osteotech, In…
Theken Surgical,Llc2005—
*K003155Vertebral Body Replacement
Summary page 1
…hopedic, Product Code: MQP, Panel Code: 87 Predicate Device: Theken Surgical, LLC-Reveal VBR System (KO50058) Osteotech, Inc. - VBR (K003155) Osteotech, Inc. - VBR (K012254) Synthes (USA) - Synex Spacer System Mater…
Osteotech, Inc.2001—
*K012254VBR
Summary page 1
…e: Theken Surgical, LLC-Reveal VBR System (KO50058) Osteotech, Inc. - VBR (K003155) Osteotech, Inc. - VBR (K012254) Synthes (USA) - Synex Spacer System Material Composition: Titanium Alloy (Ti6AI4V) per ASTM F1…
Osteotech, Inc.2001—
*K003836Synthes Synex Spacer System
Summary page 2
…steotech, Inc (K003155, SE 01/04/2001). VBR rMmanufactured by Osteotech, Inc (K012254, SE 11/16/2001). Synex Spacer System manufactured by Synthes (USA) (K003836, SE 05/29/2001). Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. Al…
Synthes200111

Also cleared against K050058: 6 other devices →

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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • 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 x.POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture). The x.POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft…

Read the full statement (116 words)

The x.POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).

The x.POD Adjustable Vertebral Body Replacement 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. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.

The x.POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 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
  • K070381Theken VU Mesh VBR SystemTheken 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/K070786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070786: X-Pod Adjustable Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070786

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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