# K151056: Aesculap T-Space PEEK and XP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Aug 13, 2015 after 115 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 13 generations back to K003155 (2001). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122967: Lucent, Spinal Elements, Inc. (2013) Summary page 6.
- K060762: Aesculap Peek Vertebral Body Replacement System, Aesculap, Inc. (2006) Summary page 6.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 6.
- K123909: Aesculap Cespace XP, Aesculap Implant System, Inc. (2013) Summary page 6.
- K132421: Aesculap Peek XP Spinal Implant System, Aesculap Implant Systems, Inc. (2014) Summary page 6.

## Indications for use
When used as an Intervertebral Body Fusion System: The T-Space Spinal Implant System are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) 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. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The AIS T-Space Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The AIS T-Space Spinal Implant System implants can be used individually or in pairs. The AIS T-Space Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

Source page: https://510kreport.com/device/K151056
Methodology: https://510kreport.com/methodology