# K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: May 1, 2008 after 287 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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: 10 generations back to K003155 (2001). 37 ancestors in all.
788 later devices descend from it; 12 cite it directly.
1 of 826 devices in its family (counting itself) has 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.
- K071724: Lucent, Spinal Elements, Inc. (2007). Cleared while this submission was under review Summary page 1.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K100889: Endoskeleton TC (2010), 455 descendants of its own

## Recalls of this device
- Jun 18, 2013 · Class II · Z-1806-2013: Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of

## 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 A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants 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 Aesculap PEEK 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 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 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/K071983
Methodology: https://510kreport.com/methodology