# K211689: KEYSTONE PEEK Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sanyou Medical Co, Ltd.
- Decided: Sep 21, 2021 after 111 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: 17 generations back to K841189 (1984). 124 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 5.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.
- K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K163422: Shanghai Sanyou PEEK Cage System, Shanghai Sanyou Medical Co, Ltd. (2017) Summary page 5.

## Most influential descendants
- K230872: Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (2023), 1 descendant of its own
- K254017: SWINGO-3D Lumbar Cage System (2026), 0 descendants of its own

## Indications for use
The KEYSTONE PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 toS1 whose condition requires use of interbody fusion combined with supplemental fixation. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the KEYSTONE PEEK Cage System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. Patients should have had six months of non-operative treatment prior to surgery. The KEYSTONE PEEK Cage System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. When used for these indications, the KEYSTONE PEEK Cage System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These implants may be implanted via a minimally invasive lateral approach.

Source page: https://510kreport.com/device/K211689
Methodology: https://510kreport.com/methodology