# K122518: Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa Cage

- Pathway: 510(k) (Special)
- Applicant: Bm Korea Co., Ltd.
- Decided: Feb 15, 2013 after 182 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: 12 generations back to K003155 (2001). 84 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111820: Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage, Bm Korea Co., Ltd. (2012)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K110650: Zyston Arc Interbody Spacer, Biomet Spine (Aka Ebi, LLC) (2011)
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010)
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 2.

## Most influential descendants
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K183243: Velofix TLIF Cage (2019), 0 descendants of its own

## Indications for use
The SYNSTERt CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) 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, PTLIF and TLIF) CAGE, RHEA0 PLIF CAGE and TALONO TLWF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to SI1, in skeletally mature patients who have had six months of non-operative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD 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/K122518
Methodology: https://510kreport.com/methodology