Twin Peaks
Twin Peaks is a lumbar interbody fusion system with PEEK cages in PLIF, PLIF BS, TLIF and OLIF configurations. The cages are offered in different heights and lengths to match the treated…
Twin Peaks is a lumbar interbody fusion system with PEEK cages in PLIF, PLIF BS, TLIF and OLIF configurations. The cages are offered in different heights and lengths to match the treated anatomy.
PLIF and TLIF implants have lordotic forms, while OLIF implants have no lordosis. Tantalum markers make the implants visible on radiographs, with two markers in PLIF and OLIF cages and three in TLIF cages.
Listed Item
Lumbar Cage Bullet Shaped H14/ L20/ 4°
Fusion Construct
The implants are supplied sterile with instruments for implantation. They are used with autogenous bone graft and supplemental lumbar fixation at one or two adjacent levels from L2 to S1 in skeletally mature patients.
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 | Spineway SA, France |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K152355 |
| Record published | 2016-03-17 |
| Record revised | 2025-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 7 to 15 mm; angle 0 to 9 °; length 20 to 35 mm |
| Distribution end date | 2024-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Height 8 mm | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Height 9 mm | In distribution |
| 1 | Height 14 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Height 7 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Height 12 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Height 12 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Angle 0 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Height 8 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Height 13 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Height 13 mm | In distribution |
| 1 | Height 9 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 4 ° | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Height 11 mm | In distribution |
| 1 | Angle 9 ° | In distribution |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Height 8 mm | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Length 25 mm | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Height 13 mm | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Length 25 mm | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Height 7 mm | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Length 25 mm | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 0 ° | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Length 20 mm | Withdrawn |
| 1 | Height 12 mm | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Angle 8 ° | Withdrawn |
| 1 | Length 20 mm | Withdrawn |
| 1 | Angle 4 ° | Withdrawn |
| 1 | Angle 4 ° | 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 |
|---|---|
| K152355 | 2015-12-10 |
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.