KEDGE LUMBAR IMPACTED CAGE SYSTEM
The KEDGE Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
Lumbar interbody fusion device(s), which may be implanted:
- bi-laterally via a posterior (PLIF) approach;
- as a single device via a transforaminal (TLIF) approach.
- LUMBAR CAGE
- LUMBAR Z CAGE
- LUMBAR TLIF CAGE
Benefits
Self-distracting, bulleted tip.
Convex-shaped Implants are designed to fit patient anatomy and to allow more accurate sizing.
Teeth on the surface reduce likelihood of expulsion.
Indication
Lumbar intervertebral body fusion device, Interbody Fusion System 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Size Chart
| Part No. | Description |
|---|---|
| MS-GP0108022 | 8/22mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0108026 | 8/26mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0110022 | 10/22mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0110026 | 10/26mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0112022 | 12/22mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0112026 | 12/26mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0114022 | 14/22mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0114026 | 14/26mm KEDGE Lumbar Impacted Cage PEEK |
| MS-GP0308032 | 8/32mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0310032 | 10/32mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0312032 | 12/32mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0314032 | 14/32mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0308036 | 8/36mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0310036 | 10/36mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0312036 | 12/36mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GP0314036 | 14/36mm KEDGE Lumbar Impacted Z Cage PEEK |
| MS-GT0108022 | 8/22mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0108026 | 8/26mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0110022 | 10/22mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0110026 | 10/26mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0112022 | 12/22mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0112026 | 12/26mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0114022 | 14/22mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0114026 | 14/26mm KEDGE Lumbar Impacted Cage TAV |
| MS-GT0308032 | 8/32mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0310032 | 10/32mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0312032 | 12/32mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0314032 | 14/32mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0308036 | 8/36mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0310036 | 10/36mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0312036 | 12/36mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GT0314036 | 14/36mm KEDGE Lumbar Impacted Z Cage TAV |
| MS-GP0407028 | 7×10×28mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0409028 | 9×10×28mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0411028 | 11×10×28mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0413028 | 13×10×28mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0415028 | 15×10×28mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0407031 | 7×12×31mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0409031 | 9×12×31mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0411031 | 11×12×31mm KEDGE Lumbar Impacted Cage TLIF PEEK |
| MS-GP0413031 | 13×12×31mm KEDGE Lumbar Impacted Cage TLIF PEEK |
Clinical Data
Product IFU
Note: IFU will be displayed after MDR Certification