510(k) · Cleared
Recalled · 2011Theken Cpod/Lpod Vertebral Body Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Surgical,Llc · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 20, 2004 as substantially equivalent to K022793 (Signus Medical, LLC, 2003) and 2 other predicates after a 232-day review. Its family tree reaches back 4 generations to 1984. 1 of the 1,287 devices in its family, counting itself, has a Class I recall. 1,280 later devices descend from it. It has been recalled once.
- Decided
- Feb 20, 2004
- Review
- 232 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K841189 (1984). 6 ancestors in all. 1,280 later devices descend from it, 8 citing it directly. 1 of the 1,287 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 2 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 1 generation backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- This deviceK032064 Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc · 2004
- Descendant · cites it directly · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005
- Descendant · 2 generations on · 903 of its ownK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- Descendant · 2 generations on · 902 of its ownK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- Descendant · 2 generations on · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- Descendant · 2 generations on · 864 of its ownK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010
Showing 5 of 1,280 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,280 · See all- K043479MC+ Partial VBRLdr Spine USA · 2005 · cites it directly1,214descendants
- K080728LDR Spine Roi-C ImplantLdr Spine USA · 2008 · 2 generations on903descendants
- K083857LDR Spine Roi-C ImplantLdr Spine USA · 2009 · 2 generations on902descendants
- K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · 2 generations on901descendants
- K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010 · 2 generations on864descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −3 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −2 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −1 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| 0 (this device) | K032064 | Theken Cpod/Lpod Vertebral Body Replacement System | Theken Surgical,Llc | 2004 | — |
| +1 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| +2 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| +2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| +2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| +2 | K100042 | Difusion Technologies Xiphos Interbody Fusion System | Difusion Technologies | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 21 | 0 |
| 2012 | 30 | 0 |
| 2013 | 38 | 0 |
| 2014 | 61 | 0 |
| 2015 | 68 | 0 |
| 2016 | 78 | 0 |
| 2017 | 112 | 0 |
| 2018 | 103 | 0 |
| 2019 | 101 | 0 |
| 2020 | 97 | 0 |
| 2021 | 88 | 1 |
| 2022 | 83 | 0 |
| 2023 | 106 | 0 |
| 2024 | 107 | 0 |
| 2025 | 82 | 0 |
| 2026 | 78 | 0 |
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 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022793 | Tetris Spinal ImplantSummary page 1…060) Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Predicate Device: SIGNUS Medical LLC TetrisTM Spinal Implant (K022793) Comparative Device: DePuy AcroMed, Inc. Stackable Cage TM System (K990148) Synth… | 2003 |
| * | K990148 | Stackable Cage SystemSummary page 1…87 Predicate Device: SIGNUS Medical LLC TetrisTM Spinal Implant (K022793) Comparative Device: DePuy AcroMed, Inc. Stackable Cage TM System (K990148) Synthes Spine Company, L.P. Synthes Synex TM Spacer System (… | 1999 |
| * | K003836 | Synthes Synex Spacer SystemSummary page 1…, Inc. Stackable Cage TM System (K990148) Synthes Spine Company, L.P. Synthes Synex TM Spacer System (K003836) Osteotech Inc., VBR TM (K003155) Material Composition: Titanium Ti-6A1-4V (ELI) pe… | 2001 |
| † | K003155 | Vertebral Body Replacement | 2001 |
What descends from it? (1,280)
See all 1,2808 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043479 | MC+ Partial VBR | 2005 | 1,214 |
| K050058 | Theken Reveal VBR System | 2005 | 727 |
| K062151 | Box Peek VBR System | 2006 | 175 |
| K071031 | VU E*Pod Vertebral Body Replacement | 2007 | 119 |
| K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | 2017 | 61 |
| K183083 | Shoreline Cervical Interbody RT System | 2019 | 60 |
| K072326 | Ostapek VBR System | 2008 | 1 |
| K050997 | Expanse Vertebral Body Replacement Device | 2005 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 18, 2011 | Not classified | Z-2202-2011 | Other | Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool)… |
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 20 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K043479 (Ldr Spine USA, 2005) has gone furthest, with 1,214 descendants of its own.
- 5 other devices also cite its predicate K022793.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.e. TI to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).
The CPOD/LPOD 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 to be packed into the interior openings of the device prior to implantation.
The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation systems such as the Theken Body Form Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032064: Theken Cpod/Lpod Vertebral Body Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032064
Report an extraction error
Are you the manufacturer?
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