# K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage

- Pathway: 510(k) (Traditional)
- Applicant: Bm Korea Co., Ltd.
- Decided: Mar 14, 2012 after 260 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: 11 generations back to K003155 (2001). 68 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 2.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 2.
- K082848: Nubic and Rabea Devices, Signus Medizintechnik GmbH (2009) Summary page 2.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 2.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K122872: Intervertebral Body Fusion Device (2013), 16 descendants of its own
- K132926: Velofixtm Interbody Fusion System (2014), 10 descendants of its own
- K140864: Veloxtm Interbody Fusion System (2014), 9 descendants of its own
- K172424: Velofix™ SA Cervical Cage (2017), 5 descendants of its own
- K171749: Velofix (tm) Interbody Fusion System (2017), 5 descendants of its own

## Indications for use
The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The SYNSTER (ALIF, PLIF, PTLIE and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K111820
Methodology: https://510kreport.com/methodology