Idys™- LIF
Idys LIF is a family of lumbar interbody cages and associated surgical instruments. The hollow PEEK cages support the space between lumbar or lumbosacral vertebral bodies during fusion and…
Idys LIF is a family of lumbar interbody cages and associated surgical instruments. The hollow PEEK cages support the space between lumbar or lumbosacral vertebral bodies during fusion and hold autogenous bone graft. Tantalum markers provide radiographic reference points.
Cage shapes vary with the approach: PLIF spacers have graft openings on the top, bottom and sides, while TLIF cages have a bullet-shaped leading tip. PTLIF cages are designed for an oblique position.
Listed Item
Tlif Cage Inserter
Insertion Instruments
The TLIF cage holder clamps to the cage axle, allowing the implant to rotate during insertion. A listed TLIF inserter belongs to this instrument side of the family. The cages are intended for use with supplemental spinal 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 | Clariance, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K131178 |
| Record published | 2018-06-06 |
| Record revised | 2025-12-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 7 to 16 mm; depth 11 to 32 mm; width 11 to 33 mm |
| Distribution end date | 2018-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06705111 | Height 11 mm | In distribution |
| 04522512-S | Height 12 mm | In distribution |
| 04522811-S | Height 11 mm | In distribution |
| 04522010-S | Height 10 mm | In distribution |
| 04522808-S | Height 8 mm | In distribution |
| 06533316-S | Height 16 mm | In distribution |
| 06705109 | Height 9 mm | In distribution |
| 06533313-S | Height 13 mm | In distribution |
| 04522013-S | Height 13 mm | In distribution |
| 06532907-S | Height 7 mm | In distribution |
| 04522810-S | Height 10 mm | In distribution |
| 04523213-S | Height 13 mm | In distribution |
| 04523209-S | Height 9 mm | In distribution |
| 06533310-S | Height 10 mm | In distribution |
| 04522511-S | Height 11 mm | In distribution |
| 06533307-S | Height 7 mm | In distribution |
| 04522008-S | Height 8 mm | In distribution |
| 06532913-S | Height 13 mm | In distribution |
| 06533309-S | Height 9 mm | In distribution |
| 04523212-S | Height 12 mm | In distribution |
| 06532911-S | Height 11 mm | In distribution |
| 06533315-S | Height 15 mm | In distribution |
| 04522814-S | Height 14 mm | In distribution |
| 04522813-S | Height 13 mm | In distribution |
| 06705110 | Height 10 mm | In distribution |
| 04522513-S | Height 13 mm | In distribution |
| 04523208-S | Height 8 mm | In distribution |
| 04523210-S | Height 10 mm | In distribution |
| 04522514-S | Height 14 mm | In distribution |
| 06533312-S | Height 12 mm | In distribution |
| 06532909-S | Height 9 mm | In distribution |
| 04522012-S | Height 12 mm | In distribution |
| 04522809-S | Height 9 mm | In distribution |
| 04522009-S | Height 9 mm | In distribution |
| 06533308-S | Height 8 mm | In distribution |
| 04522508-S | Height 8 mm | In distribution |
| 06532914-S | Height 14 mm | In distribution |
| 06705112 | Height 12 mm | In distribution |
| 06532908-S | Height 8 mm | In distribution |
| 04522011-S | Height 11 mm | In distribution |
| 04523211-S | Height 11 mm | In distribution |
| 04522812-S | Height 12 mm | In distribution |
| 06705114 | Height 14 mm | In distribution |
| 06705113 | Height 13 mm | In distribution |
| 06532910-S | Height 10 mm | In distribution |
| 06715006 | In distribution | |
| 06532912-S | Height 12 mm | In distribution |
| 06533314-S | Height 14 mm | In distribution |
| 04522510-S | Height 10 mm | In distribution |
| 06533311-S | Height 11 mm | In distribution |
| 06705108 | Height 8 mm | In distribution |
| 04523214-S | Height 14 mm | In distribution |
| 04522509-S | Height 9 mm | In distribution |
| 04522815-S | Height 15 mm | Withdrawn |
| 04522516-S | Height 16 mm | Withdrawn |
| 04522515-S | Height 15 mm | Withdrawn |
| 04522816-S | Height 16 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 |
|---|---|
| K243670 | 2024-12-31 |
| K200919 | 2021-04-12 |
| K200920 | 2020-05-29 |
| K183259 | 2019-03-01 |
| K172465 | 2017-12-15 |
| K131178 | 2013-10-10 |
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.