# K100516: Anyplus Peek Cages

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Dec 3, 2010 after 283 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 1 generation back to P960025 (1999). 2 ancestors in all.
636 later devices descend from it; 12 cite it directly.
1 of 639 devices in its family (counting itself) has 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 1.
- K090887: Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion Cages, SpineCraft (2009) Summary page 1.

## Most influential descendants
- K131082: Interform Interbody Cage System (2013), 595 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own

## Indications for use
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Source page: https://510kreport.com/device/K100516
Methodology: https://510kreport.com/methodology