Rampart-T
Rampart-T is a lumbar interbody fusion implant range used with bone graft to stabilize spinal segments. Each implant sits in the disc space between adjacent vertebrae and contains a hollow…
Rampart-T is a lumbar interbody fusion implant range used with bone graft to stabilize spinal segments. Each implant sits in the disc space between adjacent vertebrae and contains a hollow core for graft material.
The implant body is PEEK-OPTIMA LT1 with tantalum markers. Different heights and configurations accommodate the interbody space, and a separate insertion instrument allows the implant to be positioned and manipulated during placement.
Listed Item
Rampart T Trial, 11×30
Graft and Fixation
The hollow core accommodates autograft or allograft composed of cancellous or corticocancellous bone. Rampart-T is used as part of a fusion construct with supplemental lumbar fixation.
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 | Spineology Inc., 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 | Manufacturer |
| 510(k) | K163409 |
| Record published | 2015-10-05 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 7 to 16 mm; height 7 mm |
| Distribution end date | 2021-05-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83-01-05-10 | Length 10 mm | In distribution |
| 83-01-16-16 | Length 16 mm | In distribution |
| 83-01-16-13 | 13×30 | In distribution |
| 83-01-19-10 | Length 10 mm | In distribution |
| 83-01-05-13 | 13×30 | In distribution |
| 83-01-16-12 | Length 12 mm | In distribution |
| 83-01-04-12 | Length 12 mm | In distribution |
| 83-01-04-7 | Length 7 mm | In distribution |
| 83-01-05-11 | 11×30 | In distribution |
| 83-01-06-10 | Length 10 mm | In distribution |
| 83-01-06-8 | Length 8 mm | In distribution |
| 83-01-19-13 | Length 13 mm | In distribution |
| 83-01-19-16 | 16×35 | In distribution |
| 83-01-04-11 | Length 11 mm | In distribution |
| 83-01-16-14 | 14×30 | In distribution |
| 83-01-16-15 | Length 15 mm | In distribution |
| 83-01-06-7 | 7×35 | In distribution |
| 83-01-04-10 | Length 10 mm | In distribution |
| 83-01-04-14 | Length 14 mm | In distribution |
| 83-01-16-9 | Length 9 mm | In distribution |
| 83-01-19-8 | 8×35 | In distribution |
| 83-01-06-16 | 16×35 | In distribution |
| 83-01-05-12 | Length 12 mm | In distribution |
| 83-01-05-16 | 16×30 | In distribution |
| 83-01-16-7 | Length 7 mm | In distribution |
| 83-01-05-14 | Length 14 mm | In distribution |
| 83-01-04-13 | 13×25 | In distribution |
| 83-01-16-11 | 11×30 | In distribution |
| 83-01-06-14 | Length 14 mm | In distribution |
| 83-01-16-8 | Length 8 mm | In distribution |
| 83-01-19-9 | Length 9 mm | In distribution |
| 83-01-19-7 | Length 7 mm | In distribution |
| 83-01-19-15 | 15×35 | In distribution |
| 83-01-04-8 | 8×25 | In distribution |
| 83-01-19-11 | 11×35 | In distribution |
| 83-01-06-9 | Length 9 mm | In distribution |
| 83-01-04-9 | Length 9 mm | In distribution |
| 83-01-06-13 | Length 13 mm | In distribution |
| 83-01-05-8 | 8×30 | In distribution |
| 83-01-19-14 | 14×35 | In distribution |
| 83-01-16-10 | 10×30 | In distribution |
| 83-01-05-15 | Length 15 mm | In distribution |
| 83-01-05-9 | 9×30 | In distribution |
| 83-01-05-7 | Length 7 mm | In distribution |
| 83-01-06-15 | 15×35 | In distribution |
| 83-01-06-11 | 11×35 | In distribution |
| 83-01-04-15 | Length 15 mm | In distribution |
| 83-01-06-12 | Length 12 mm | In distribution |
| 83-01-19-12 | 12×35 | In distribution |
| 83-01-04-16 | 16×25 | In distribution |
| 83-03-01-8 | Withdrawn | |
| 83-03-01-11 | Withdrawn | |
| 83-03-34-15 | Withdrawn | |
| 83-03-01-16 | Withdrawn | |
| 83-03-34-7 | Withdrawn | |
| 83-03-01-15 | Withdrawn | |
| 83-03-34-8 | Withdrawn | |
| 83-03-34-13 | Withdrawn | |
| 83-03-01-13 | Withdrawn | |
| 83-03-34-14 | Withdrawn | |
| 83-03-34-12 | Withdrawn | |
| 83-03-01-10 | Withdrawn | |
| 83-03-34-11 | Withdrawn | |
| 83-03-01-9 | Withdrawn | |
| 83-03-34-9 | Withdrawn | |
| 83-03-03 | Withdrawn | |
| 83-03-34-10 | Withdrawn | |
| 83-03-34-16 | Withdrawn | |
| 83-03-01-12 | Withdrawn | |
| 83-03-01-14 | Withdrawn | |
| 83-03-01-7 | Height 7 mm | Withdrawn |
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 |
|---|---|
| K210155 | 2021-02-19 |
| K190055 | 2019-03-07 |
| K182322 | 2018-10-24 |
| K181792 | 2018-08-14 |
| K171660 | 2017-08-18 |
| K171724 | 2017-07-24 |
| K163409 | 2017-03-08 |
| K162879 | 2017-01-30 |
| K160074 | 2016-10-18 |
| K160906 | 2016-07-14 |
| K153082 | 2016-02-04 |
| K151020 | 2015-07-22 |
| K133371 | 2014-01-09 |
| K132053 | 2013-09-16 |
| K131216 | 2013-05-30 |
| K130396 | 2013-03-25 |
| K123652 | 2013-03-22 |
| K121129 | 2012-06-13 |
| K120293 | 2012-02-29 |
| K113030 | 2012-01-26 |
| K111880 | 2011-09-26 |
| K110933 | 2011-06-13 |
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.