# K163422: Shanghai Sanyou PEEK Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sanyou Medical Co, Ltd.
- Decided: Sep 18, 2017 after 286 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 16 generations back to K841189 (1984). 123 ancestors in all.
3 later devices descend from it; 3 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)
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 5.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 5.
- K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K153373: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device, Medtronic Sofamor Danek (2016) Summary page 5.

## Most influential descendants
- K211689: KEYSTONE PEEK Cage System (2021), 2 descendants of its own
- 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 Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These 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. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5. The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-Tl. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use. The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K163422
Methodology: https://510kreport.com/methodology