Endoskeleton TO
Endoskeleton TO is a lumbar interbody fusion implant range that provides mechanical stability in the disc space while fusion develops. The implants are used with autograft bone and…
Endoskeleton TO is a lumbar interbody fusion implant range that provides mechanical stability in the disc space while fusion develops. The implants are used with autograft bone and supplemental spinal fixation.
The implanted components are medical-grade titanium alloy. Different implant sizes accommodate anatomical variation, and associated placement instruments support installation of the interbody component.
Listed Item
Interbody Fusion Device nanoLOCK Surface Technology 0 Degree Convex Oblique 13mm
Fusion Assembly
The system is intended for one or two contiguous lumbar levels from L2 through S1 in skeletally mature patients with degenerative disc disease, sometimes accompanied by low-grade spondylolisthesis or retrolisthesis.
14manufacturers in China registered for this device type
195catalogue numbers in this listing
7510(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 | Titan Spine, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K102067 |
| Record published | 2015-09-17 |
| Record revised | 2022-09-16 (version 12) |
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 | Width 9 to 31 mm; height 8 to 16 mm; depth 9 to 11 mm; angle 4 °; length 13 to 21 in; width 10 in; height 4 in |
| Distribution end date | 2020-09-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3110-2211-S | 0 Deg Convex | Withdrawn |
| 3110-2216-S | 0 Deg Convex | Withdrawn |
| 3114-3109 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2209-S | 0 Deg Convex | Withdrawn |
| 3110-2214-N | Height 14 mm | Withdrawn |
| 3110-3109-S | Height 9 mm | Withdrawn |
| 3114-3115 | Width 31 mm | Withdrawn |
| 3110-2610-N | 0 Deg Convex | Withdrawn |
| 3110-2610 | Height 10 mm | Withdrawn |
| 3110-3116-S | Height 16 mm | Withdrawn |
| 3114-2615 | Height 15 mm | Withdrawn |
| 3210-2208 | Height 8 mm | Withdrawn |
| 3114-2613-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2211 | Height 11 mm | Withdrawn |
| 3110-2215 | Height 15 mm | Withdrawn |
| 3114-2208 | Height 8 mm | Withdrawn |
| 3110-3110-S | Height 10 mm | Withdrawn |
| 3114-2616 | width(MLxAP), 26 x 9, mm | Withdrawn |
| 3110-2610-S | 0 Deg Convex | Withdrawn |
| 3110-2210 | 0 Deg Convex | Withdrawn |
| 3110-2608-S | 0 Deg Convex | Withdrawn |
| 3110-3110 | 0 Deg Convex | Withdrawn |
| 3110-2608 | Height 8 mm | Withdrawn |
| 3110-2612 | 0 Deg Convex | Withdrawn |
| 3110-2609-S | Height 9 mm | Withdrawn |
| 3114-2216 | Height 16 mm | Withdrawn |
| 3114-2215-S | Height 15 mm | Withdrawn |
| 3110-3115-S | Height 15 mm | Withdrawn |
| 3114-3113 | Height 13 mm | Withdrawn |
| 3110-2215-N | 0 Deg Convex | Withdrawn |
| 3114-2609-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2216-N | 0 Deg Convex | Withdrawn |
| 3110-3113-N | Depth 11 mm | Withdrawn |
| 3110-2216 | Height 16 mm | Withdrawn |
| 3110-2608-N | Height 8 mm | Withdrawn |
| 3110-2213-S | Height 13 mm | Withdrawn |
| 3114-3114 | Height 14 mm | Withdrawn |
| 3114-2608 | Height 8 mm | Withdrawn |
| 3114-3109-N | Height 9 mm | Withdrawn |
| 3110-2212-N | 0 Deg Convex | Withdrawn |
| 3210-2212 | Height 12 mm | Withdrawn |
| 3114-3110 | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3900-1011 | Width 10 in | Withdrawn |
| 3110-2616-N | Height 16 mm | Withdrawn |
| 3210-2209 | Height 9 mm | Withdrawn |
| 3110-2611-S | Height 11 mm | Withdrawn |
| 3210-2215 | Height 15 mm | Withdrawn |
| 3114-2615-S | Height 15 mm | Withdrawn |
| 3114-3114 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2611-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3110-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-3111-N | 0 Deg Convex | Withdrawn |
| 3210-2214 | Height 14 mm | Withdrawn |
| 3110-3109 | 0 Deg Convex | Withdrawn |
| 3114-2213-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2209-N | Height 9 mm | Withdrawn |
| 3114-2609-S | Height 9 mm | Withdrawn |
| 3110-2612-N | Height 12 mm | Withdrawn |
| 3114-2208-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3112 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3114-N | Height 14 mm | Withdrawn |
| 3110-2614 | 0 Deg Convex | Withdrawn |
| 3210-0001 | Length 14 in | Withdrawn |
| 3210-2210 | Height 10 mm | Withdrawn |
| 3114-3109 | Angle 4 ° | Withdrawn |
| 3114-3108-N | Height 8 mm | Withdrawn |
| 3114-2610 | Height 10 mm | Withdrawn |
| 3110-2616 | 0 Deg Convex | Withdrawn |
| 3110-2614-N | Height 14 mm | Withdrawn |
| 3110-2209-N | Height 9 mm | Withdrawn |
| 3110-2611 | 0 Deg Convex | Withdrawn |
| 3110-3108-S | Height 8 mm | Withdrawn |
| 3114-2210-S | Height 10 mm | Withdrawn |
| 3114-3112-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3108-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2213 | Height 13 mm | Withdrawn |
| 3114-3115-S | Height 15 mm | Withdrawn |
| 3110-2614-S | Height 14 mm | Withdrawn |
| 3210-3116 | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3110-3114-S | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3110-2609-N | Height 9 mm | Withdrawn |
| 3110-3113-S | 0 Deg Convex | Withdrawn |
| 3114-2211 | Height 11 mm | Withdrawn |
| 3114-2211-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2212-S | Height 12 mm | Withdrawn |
| 3114-3116 | Depth 11 mm | Withdrawn |
| 3110-3114 | 0 Deg Convex | Withdrawn |
| 3114-3108 | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3114-2612 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2209 | Lordotic Angle 4 Deg | Withdrawn |
| 3210-2213 | Height 13 mm | Withdrawn |
| 3114-2214 | Lordotic Angle 4 Deg | Withdrawn |
| 3900-1001-10 | Withdrawn | |
| 3114-2610-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2209 | 0 Deg Convex | Withdrawn |
| 3110-3115 | Height 15 mm | Withdrawn |
| 3114-2210 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-3114-N | 0 Deg Convex | Withdrawn |
| 3110-2609 | Height 9 mm | Withdrawn |
| 3114-2208-S | Height 8 mm | Withdrawn |
| 3114-2609 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-3112-N | 0 Deg Convex | Withdrawn |
| 3114-2211-N | Height 11 mm | Withdrawn |
| 3114-3115-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3109-S | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2208 | 0 Deg Convex | Withdrawn |
| 3114-2215-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3115 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2615-S | Height 15 mm | Withdrawn |
| 3114-2212 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2614-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2215 | Height 15 mm | Withdrawn |
| 3114-2616-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3110-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3113-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-3116 | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3114-3116 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2209-S | Height 9 mm | Withdrawn |
| 3110-2208-N | 0 Deg Convex | Withdrawn |
| 3110-3109-N | Height 9 mm | Withdrawn |
| 3114-2614 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2214 | Height 14 mm | Withdrawn |
| 3114-2216-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2614-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2615-N | Height 15 mm | Withdrawn |
| 3114-3116-N | Depth 11 mm | Withdrawn |
| 3114-2616-N | Height 16 mm | Withdrawn |
| 3110-2211-N | Height 11 mm | Withdrawn |
| 3210-0002 | Length 14 in | Withdrawn |
| 3114-2610-S | Height 10 mm | Withdrawn |
| 3114-2611 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2616-S | Height 16 mm | Withdrawn |
| 3110-2613-N | Height 13 mm | Withdrawn |
| 3114-3108 | Height 8 mm | Withdrawn |
| 3114-3113 | Depth 11 mm | Withdrawn |
| 3110-2210-N | Height 10 mm | Withdrawn |
| 3114-2613 | Height 13 mm | Withdrawn |
| 3114-2608-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3111 | Width 31 mm | Withdrawn |
| 3110-3112 | Height 12 mm | Withdrawn |
| 3110-2214-S | Height 14 mm | Withdrawn |
| 3110-2213 | Height 13 mm | Withdrawn |
| 3110-3108 | Height 8 mm | Withdrawn |
| 3114-2210-N | Lordotic Angle 4 Deg | Withdrawn |
| 3900-1011 | Length 21 in | Withdrawn |
| 3110-2215-S | 0 Deg Convex | Withdrawn |
| 3900-1001 | Width 10 in | Withdrawn |
| 3114-3113-S | Height 13 mm | Withdrawn |
| 3114-3114-S | Height 14 mm | Withdrawn |
| 3900-1001 | Length 21 in | Withdrawn |
| 3114-2613-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3111-S | Lordotic Angle 4 Deg | Withdrawn |
| 586-000-001 | Withdrawn | |
| 3114-2612-S | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2212 | Height 12 mm | Withdrawn |
| 3110-2613 | 0 Deg Convex | Withdrawn |
| 3110-2616 | width(MLxAP), 26 x 9, mm | Withdrawn |
| 3114-3110 | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3112-S | Height 12 mm | Withdrawn |
| 3114-2616 | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2611-N | Height 11 mm | Withdrawn |
| 3110-3108-N | Depth 11 mm | Withdrawn |
| 3114-2608-S | Height 8 mm | Withdrawn |
| 3110-2615 | Height 15 mm | Withdrawn |
| 3114-2214-S | Height 14 mm | Withdrawn |
| 3110-2208-S | Height 8 mm | Withdrawn |
| 3114-3112 | width(MLxAP), 31 x 11, mm | Withdrawn |
| 3114-2212-N | Height 12 mm | Withdrawn |
| 3110-3112-S | Height 12 mm | Withdrawn |
| 3114-2615-N | Width 26 mm | Withdrawn |
| 3114-2611-N | width(MLxAP), 26 x 9, mm | Withdrawn |
| 3114-2216 | Width 22 mm | Withdrawn |
| 3210-2211 | Height 11 mm | Withdrawn |
| 3110-3110-N | 0 Deg Convex | Withdrawn |
| 3110-3111-S | 0 Deg Convex | Withdrawn |
| 3200-4000 | Length 13 in | Withdrawn |
| 3110-3116 | Height 16 mm | Withdrawn |
| 3114-3111-N | Lordotic Angle 4 Deg | Withdrawn |
| 3110-3111 | 0 Deg Convex | Withdrawn |
| 3114-2213-S | Lordotic Angle 4 Deg | Withdrawn |
| 3110-2210-S | Height 10 mm | Withdrawn |
| 3110-2612-S | Height 12 mm | Withdrawn |
| 3110-3113 | 0 Deg Convex | Withdrawn |
| 3210-2216 | Depth 9 mm | Withdrawn |
| 3110-2216 | width(MLxAP), 22 x 9, mm | Withdrawn |
| 3110-2613-S | 0 Deg Convex | Withdrawn |
| 3114-3116-S | Lordotic Angle 4 Deg | Withdrawn |
| 3114-2612-N | width(MLxAP), 26 x 9, mm | Withdrawn |
| 3110-2212-S | Height 12 mm | Withdrawn |
| 3114-2216-N | Height 16 mm | Withdrawn |
| 3110-3116-N | 0 Deg Convex | Withdrawn |
| 3110-2213-N | Height 13 mm | Withdrawn |
| 3114-2214-N | Lordotic Angle 4 Deg | Withdrawn |
| 3114-3111 | Depth 11 mm | Withdrawn |
| 3110-3115-N | Height 15 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 |
|---|---|
| K170399 | 2017-07-06 |
| K141953 | 2014-10-27 |
| K142589 | 2014-10-17 |
| K140055 | 2014-07-02 |
| K102067 | 2010-11-05 |
| K083714 | 2009-04-15 |
| K080615 | 2008-06-17 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2021-03-17 | Class II | Packaging process control | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device. | 11 devices | 2023-05-03 |
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.