Lumbar Ibfd
Keos Lumbar IBFD cages maintain disc-space distraction during lumbar fusion. Their hollow centers hold autogenous bone graft, while fixed heights and shapes provide different implant…
Keos Lumbar IBFD cages maintain disc-space distraction during lumbar fusion. Their hollow centers hold autogenous bone graft, while fixed heights and shapes provide different implant configurations.
The material options are PEEK and hydroxyapatite-enhanced PEEK, with embedded tantalum markers. Ridges on the upper and lower surfaces grip the adjacent vertebral endplates and are designed to resist expulsion.
Approach Configurations
The system supports one or two contiguous levels from L2 to S1 with supplemental spinal fixation. A TLIF configuration uses one cage per treated space, while a PLIF configuration uses two. The implants are supplied nonsterile for autoclave sterilization.
14manufacturers in China registered for this device type
88catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Keos, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160631 |
| Record published | 2017-11-30 |
| Record revised | 2023-01-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23L x 8W x 7H Straight | In distribution | |
| 23L x 10W x 13H Straight, HA | In distribution | |
| 23L x 8W x 12H Straight, HA Enhanced | In distribution | |
| 23L x 10W x 13H Straight | In distribution | |
| 23L x 8W x 15H Straight | In distribution | |
| 23L x 8W x 9H Straight | In distribution | |
| 23L x 8W x 9H Straight, HA Enhanced | In distribution | |
| 23L x 10W x 7H Straight, HA | In distribution | |
| 23L x 8W x 15H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 12H Curved | In distribution | |
| 23L x 10W x 16H Straight | In distribution | |
| 28L x 10W x 7H Curved | In distribution | |
| 23L x 10W x 6H Straight | In distribution | |
| 28L x 10W x 12H Straight | In distribution | |
| 23L x 10W x 15H Straight, HA | In distribution | |
| 28L x 10W x 15H Straight, HA | In distribution | |
| 23L x 10W x 6H Straight, HA | In distribution | |
| 23L x 8W x 14H Straight, HA Enhanced | In distribution | |
| 23L x 10W x 9H Straight, HA | In distribution | |
| 28L x 10W x 7H Straight, HA | In distribution | |
| 23L x 8W x 16H Straight | In distribution | |
| 28L x 10W x 7H Curved, HA | In distribution | |
| 28L x 10W x 16H Straight, HA | In distribution | |
| 28L x 10W x 7H Straight | In distribution | |
| 28L x 10W x 9H Straight, HA | In distribution | |
| 23L x 10W x 14H Straight, HA | In distribution | |
| 28L x 10W x 6H Straight | In distribution | |
| 28L x 10W x 11H Curved, HA | In distribution | |
| 28L x 10W x 12H Curved, HA | In distribution | |
| 28L x 10W x 11H Straight | In distribution | |
| 28L x 10W x 10H Straight | In distribution | |
| 28L x 10W x 8H Straight, HA | In distribution | |
| 28L x 10W x 8H Curved, HA | In distribution | |
| 28L x 10W x 13H Curved, HA | In distribution | |
| 23L x 8W x 6H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 8H Straight | In distribution | |
| 28L x 10W x 6H Curved, HA | In distribution | |
| 23L x 8W x 8H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 8H Curved | In distribution | |
| 28L x 10W x 16H Curved | In distribution | |
| 23L x 10W x 8H Straight | In distribution | |
| 23L x 10W x 16H Straight, HA | In distribution | |
| 28L x 10W x 10H Straight, HA | In distribution | |
| 28L x 10W x 14H Straight | In distribution | |
| 28L x 10W x 14H Curved | In distribution | |
| 23L x 10W x 7H Straight | In distribution | |
| 23L x 8W x 11H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 9H Straight | In distribution | |
| 28L x 10W x 14H Straight, HA | In distribution | |
| 28L x 10W x 16H Curved, HA | In distribution | |
| 23L x 8W x 10H Straight | In distribution | |
| 23L x 10W x 14H Straight | In distribution | |
| 28L x 10W x 15H Curved | In distribution | |
| 23L x 8W x 6H Straight | In distribution | |
| 23L x 8W x 11H Straight | In distribution | |
| 28L x 10W x 9H Curved | In distribution | |
| 23L x 10W x 9H Straight | In distribution | |
| 23L x 10W x 8H Straight, HA | In distribution | |
| 28L x 10W x 13H Curved | In distribution | |
| 28L x 10W x 11H Straight, HA | In distribution | |
| 28L x 10W x 9H Curved, HA | In distribution | |
| 23L x 10W x 10H Straight, HA | In distribution | |
| 23L x 10W x 15H Straight | In distribution | |
| 23L x 10W x 12H Straight | In distribution | |
| 28L x 10W x 13H Straight, HA | In distribution | |
| 23L x 8W x 16H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 14H Curved, HA | In distribution | |
| 28L x 10W x 15H Curved, HA | In distribution | |
| 23L x 10W x 12H Straight, HA | In distribution | |
| 28L x 10W x 11H Curved | In distribution | |
| 28L x 10W x 10H Curved, HA | In distribution | |
| 28L x 10W x 6H Curved | In distribution | |
| 23L x 8W x 10H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 6H Straight, HA | In distribution | |
| 23L x 10W x 11H Straight, HA | In distribution | |
| 23L x 8W x 12H Straight | In distribution | |
| 23L x 8W x 7H Straight, HA Enhanced | In distribution | |
| 28L x 10W x 12H Straight, HA | In distribution | |
| 23L x 10W x 10H Straight | In distribution | |
| 23L x 8W x 13H Straight | In distribution | |
| 28L x 10W x 15H Straight | In distribution | |
| 28L x 10W x 13H Straight | In distribution | |
| 23L x 8W x 8H Straight | In distribution | |
| 28L x 10W x 10H Curved | In distribution | |
| 28L x 10W x 16H Straight | In distribution | |
| 23L x 10W x 11H Straight | In distribution | |
| 23L x 8W x 13H Straight, HA Enhanced | In distribution | |
| 23L x 8W x 14H Straight | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193174 | 2019-12-16 |
| K163386 | 2017-04-10 |
| K160631 | 2016-07-15 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.