# K132421: Aesculap Peek XP Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Jan 22, 2014 after 170 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). 38 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 53 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.

## Most influential descendants
- K180590: Tyber Medical PT Interbody Spacer System (2018), 6 descendants of its own
- K182284: Tyber Medical PT Interbody Spacer (2019), 5 descendants of its own
- K173082: Arco™-SA Lumbar Cage System (2018), 5 descendants of its own
- K182195: Arco™-SA Lumbar Cage System (2018), 3 descendants of its own
- K230583: Tryptik Ti (2023), 1 descendant of its own

## Indications for use
The Plasmapore® XP 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 Plasmapore® XP 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 Plasmapore® XP Spinal Implant System implants can be used individually or in pairs. The Plasmapore® XP 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 device.

Source page: https://510kreport.com/device/K132421
Methodology: https://510kreport.com/methodology