# K060762: Aesculap Peek Vertebral Body Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Sep 14, 2006 after 177 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003155 (2001). 34 ancestors in all.
789 later devices descend from it; 3 cite it directly.
1 of 824 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.
- K043316: Rabea Spinal Implant, Signus Medizintechnik GmbH (2005) Summary page 1.
- K051659: Semial Spinal Implant, Signus Medizintechnik GmbH (2005)
- K052096: Nubic Spinal Implant, Signus Medical, LLC (2005) Summary page 1.
- K042201: Novel VBR Spinal System, Alphatec/Nexmed (2004) Summary page 1.
- K042571: Stryker Spine Avs TL Peek Spacer, Stryker Spine (2005) Summary page 1.
- K051205: Stryker Spine Avs Asl Peek Spacer, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), 554 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own

## Indications for use
The Aesculap PEEK Vertebral Body Replacement (VBR) System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK VBR System implants can be used individually or in pairs. The Aesculap PEEK VBR System is also intended for use with bone graft.

Source page: https://510kreport.com/device/K060762
Methodology: https://510kreport.com/methodology