# K132852: Peek Cage for the Vertebral Spine

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Produtos Ortopedicos S/A
- Decided: May 29, 2014 after 260 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: 11 generations back to K003155 (2001). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 1.
- K082848: Nubic and Rabea Devices, Signus Medizintechnik GmbH (2009) Summary page 1.

## Indications for use
The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and AUIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S 1, in skeletally mature patients with degenerative disc disease (ODD). DDD is defined as back pain of discogenic origin with degeneration of the disc conifirmed by history and radiographic studies. DDID patients may also have Grade I Spondylolisthesis or retrolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PUPF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine. The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to TI for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of tihe disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine. All lumbar and cervical devices are intended for use with autogenous bone graft.

Source page: https://510kreport.com/device/K132852
Methodology: https://510kreport.com/methodology