AnyPlus PEEK Lumbar Fusion Cage
The AnyPlus PEEK lumbar cage supports spinal fusion in skeletally mature patients with degenerative disc disease at one or two adjacent levels from L2 to S1. Use requires the patient’s own…
The AnyPlus PEEK lumbar cage supports spinal fusion in skeletally mature patients with degenerative disc disease at one or two adjacent levels from L2 to S1. Use requires the patient’s own bone graft, cleared supplemental lumbar fixation and at least six months of nonoperative treatment.
The implant occupies the disc space after disc removal, restoring its height while its open structure accepts bone graft. Available heights and lordotic shapes accommodate different lumbar approaches. Patients may have up to Grade I spondylolisthesis or retrolisthesis at the treated levels.
Materials
The cage body is made from PEEK OPTIMA LT1 polymer. Tantalum X-ray markers provide visible reference points for an otherwise radiolucent implant during imaging.
14manufacturers in China registered for this device type
282catalogue numbers in this listing
4510(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 | GS Medical Co., Ltd., South Korea |
|---|---|
| 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) | K131612 |
| Record published | 2016-04-26 |
| Record revised | 2020-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2016-04-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1103-3114 | In distribution | |
| 1103-3118 | In distribution | |
| 1148-1411 | In distribution | |
| 1103-3113 | In distribution | |
| 1168-1015 | In distribution | |
| 1103-3110 | In distribution | |
| 1141-1010 | In distribution | |
| 1108-1012 | In distribution | |
| 1108-1015 | In distribution | |
| 1168-0015 | In distribution | |
| 1168-0013 | In distribution | |
| 1148-1013 | In distribution | |
| 1101-1011 | In distribution | |
| 1101-1010 | In distribution | |
| 1101-1009 | In distribution | |
| 1101-1014 | In distribution | |
| 1148-1010 | In distribution | |
| 1168-0014 | In distribution | |
| 1161-1010 | In distribution | |
| 1103-3116 | In distribution | |
| 1148-1015 | In distribution | |
| 1141-1012 | In distribution | |
| 1109-0415 | In distribution | |
| 1101-1015 | In distribution | |
| 1148-1011 | In distribution | |
| 1141-1009 | In distribution | |
| 1148-0008 | In distribution | |
| 1103-3120 | In distribution | |
| 1161-1015 | In distribution | |
| 1161-1009 | In distribution | |
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| 1148-0013 | In distribution | |
| 1161-1011 | In distribution | |
| 1108-0009 | In distribution | |
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| 1168-0010 | In distribution | |
| 1148-1012 | In distribution | |
| 1108-1013 | In distribution | |
| 1141-1014 | In distribution | |
| 1108-0011 | In distribution | |
| 1148-1008 | In distribution | |
| 1141-1011 | In distribution | |
| 1161-1008 | In distribution | |
| 1148-1014 | In distribution | |
| 1168-0410 | In distribution | |
| 1141-1013 | In distribution | |
| 1161-1013 | In distribution | |
| 1103-3111 | In distribution | |
| 1103-3117 | In distribution | |
| 1108-0012 | In distribution | |
| 1148-0411 | In distribution | |
| 1108-0010 | In distribution | |
| 1108-0013 | In distribution | |
| 1168-1013 | In distribution | |
| 1148-1009 | In distribution | |
| 1108-0014 | In distribution | |
| 1108-1009 | In distribution | |
| 1168-1009 | In distribution | |
| 1101-1008 | In distribution | |
| 1108-0409 | In distribution | |
| 1168-0011 | In distribution | |
| 1103-3119 | In distribution | |
| 1141-1015 | In distribution | |
| 1103-3112 | In distribution | |
| 1108-0008 | In distribution | |
| 1168-1008 | In distribution | |
| 1161-1012 | In distribution | |
| 1168-1011 | In distribution | |
| 1148-0012 | In distribution | |
| 1108-1008 | In distribution | |
| 1168-1012 | In distribution | |
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| 1108-0411 | In distribution | |
| 1168-1010 | In distribution | |
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| 1141-1008 | In distribution | |
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| 1148-0015 | In distribution | |
| 1108-1010 | In distribution | |
| 1168-1014 | In distribution | |
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| 1108-1011 | In distribution | |
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Showing 250 of 282 catalogue numbers.
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 |
|---|---|
| K223868 | 2023-04-26 |
| K221687 | 2022-07-27 |
| K131612 | 2014-04-18 |
| K111354 | 2011-10-17 |
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.