# K032064: Theken Cpod/Lpod Vertebral Body Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: Feb 20, 2004 after 232 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K841189 (1984). 6 ancestors in all.
1,280 later devices descend from it; 8 cite it directly.
1 of 1,287 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.

## Most influential descendants
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own
- K080728: LDR Spine Roi-C Implant (2008), 903 descendants of its own
- K083857: LDR Spine Roi-C Implant (2009), 902 descendants of its own
- K091088: LDR Spine Cervical Interbody Fusion System (2009), 901 descendants of its own
- K100042: Difusion Technologies Xiphos Interbody Fusion System (2010), 864 descendants of its own

## Recalls of this device
- Jan 18, 2011 · Not classified · Z-2202-2011: 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 (i

## Indications for use
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).

Source page: https://510kreport.com/device/K032064
Methodology: https://510kreport.com/methodology