Endoskeleton® TCS Sterile Barrier System
The Endoskeleton TCS interbody fusion device is a titanium alloy implant placed across a cervical disc space to support fusion. It is indicated for skeletally mature patients with…
The Endoskeleton TCS interbody fusion device is a titanium alloy implant placed across a cervical disc space to support fusion. It is indicated for skeletally mature patients with degenerative disc disease at one level from C2 to T1, after at least six weeks of nonoperative treatment.
A hollow central region holds autograft bone. Acid-etched upper and lower surfaces contact the adjacent vertebral bone to help fixation. The implants are available in different sizes and lordotic angles to accommodate the disc space and patient anatomy.
Listed Item
Interbody Fusion Device 6 Degree Medium 11mm
Required Fixation
The implant forms a stand-alone system when used with Endoskeleton TCS integrated screws. Without those integrated screws, it requires additional supplemental fixation cleared for the cervical spine.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Titan Spine, LLC, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K151596 |
| Record published | 2019-09-30 |
| Record revised | 2025-07-14 (version 11) |
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, manufacturing date |
| Sizes | Depth 12 to 16 mm; width 14 to 18 mm; height 5 to 12 mm; angle 6 °; outer diameter 3.5 to 3.8 mm; length 13 to 19 mm |
| Distribution end date | 2021-03-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5301-3519-S | Outer Diameter 3.5 mm | Withdrawn |
| 5340-1207-S | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5366-1411-S | Depth 14 mm | Withdrawn |
| 5346-1212-S | Angle 6 ° | Withdrawn |
| 5380-1612-S | Width 18 mm | Withdrawn |
| 5346-1207-S | Width 14 mm | Withdrawn |
| 5386-1606-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5340-1212-S | Depth 12 mm | Withdrawn |
| 5301-3813-S | Outer Diameter 3.5 mm | Withdrawn |
| 5340-1211-S | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5302-3815-S | Outer Diameter 3.8 mm | Withdrawn |
| 5302-3819-S | Length 19 mm | Withdrawn |
| 5302-3515-S | Length 15 mm | Withdrawn |
| 5346-1211-S | Width 14 mm | Withdrawn |
| 5340-1208-S | Depth 12 mm | Withdrawn |
| 5380-1610-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5360-1406-S | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5301-3819-S | Length 19 mm | Withdrawn |
| 5340-1205-S | Width 14 mm | Withdrawn |
| 5360-1408-S | Width 16 mm | Withdrawn |
| 5366-1405-S | Width 16 mm | Withdrawn |
| 5380-1608-S | width(MLxAP), 18 x 16, mm | Withdrawn |
| 5360-1405-S | Depth 14 mm | Withdrawn |
| 5360-1411-S | Width 16 mm | Withdrawn |
| 5366-1409-S | Depth 14 mm | Withdrawn |
| 5366-1406-S | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5380-1609-S | width(MLxAP), 18 x 16, mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191565 | 2019-08-06 |
| K153122 | 2015-12-14 |
| K151596 | 2015-10-09 |
| K142940 | 2015-01-28 |
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 | 2021-09-02 | Class II | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. | 9 units | 2023-10-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-07-20 | Class II | Nonconforming Material/Component | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not ‘locking’. | 137 units | 2015-10-20 |
| 2015-02-20 | Class II | Nonconforming Material/Component | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drive | 26 | 2015-04-17 |
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.