# K123909: Aesculap Cespace XP

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Apr 15, 2013 after 117 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: 12 generations back to K003155 (2001). 40 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009)

## Most influential descendants
- K161809: ShurFit CpTi-HA ACIF Interbody Fusion System (2016), 5 descendants of its own
- K171657: ShurFit 2C Lumbar Interbody Fusion System (2017), 4 descendants of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K221182: Southern Transforaminal Lumbar Interbody Fusion (TLIF) (2022), 0 descendants of its own
- K221172: FOCUS Interbody System (2022), 0 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 (TI to L_5) 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). DOD 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/K123909
Methodology: https://510kreport.com/methodology