# K083311: Aesculap Cespace Peek Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Mar 4, 2009 after 114 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003155 (2001). 39 ancestors in all.
554 later devices descend from it; 8 cite it directly.
0 of 594 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060762: Aesculap Peek Vertebral Body Replacement System, Aesculap, Inc. (2006) Summary page 1.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- K100889: Endoskeleton TC (2010), 455 descendants of its own
- K121649: Construx Mini Peek TI Spacer System (2012), 289 descendants of its own
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), 280 descendants of its own
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL (2014), 265 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own

## Indications for use
When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant 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 Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft. When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.

Source page: https://510kreport.com/device/K083311
Methodology: https://510kreport.com/methodology