# K181963: ostaPek Interbody Fusion Cages

- Pathway: 510(k) (Traditional)
- Applicant: Coligne AG
- Decided: Nov 14, 2018 after 114 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: 15 generations back to K841189 (1984). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage, L&K BIOMED Co., Ltd. (2011) Summary page 4.
- K151140: LnK Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 4.

## Most influential descendants
- K230478: Acro Composites Interbody System (2023), 0 descendants of its own

## Indications for use
The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacrolumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K181963
Methodology: https://510kreport.com/methodology