Endoskeleton TCS
Endoskeleton TCS is a cervical interbody fusion implant range with a hollow center for autograft bone. An implant occupies the prepared disc space, and windows through the body allow…
Endoskeleton TCS is a cervical interbody fusion implant range with a hollow center for autograft bone. An implant occupies the prepared disc space, and windows through the body allow visualization of the graft and provide space for bone formation through the implant.
The implantable components are titanium alloy. Acid-etched upper and lower surfaces provide the bone-contact interface, and different implant sizes and lordotic angles accommodate differences in cervical anatomy.
Listed Item
Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 11mm
Integrated Fixation
TCS can form a stand-alone system when used with its integrated screws. Configurations used without those screws require supplemental cervical fixation. An anterior holding feature connects the implant to its placement instrument.
5manufacturers in China registered for this device type
148catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this code
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) | K142940 |
| Record published | 2016-09-17 |
| Record revised | 2024-09-11 (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 | Height 5 to 12 mm; depth 12 to 16 mm; width 14 to 18 mm; angle 6 °; outer diameter 3.5 to 3.8 mm; length 13 to 20 mm; length 1.5 to 21 in; height 1 to 6 in |
| Distribution end date | 2020-09-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5210-1046 | Length 6 in | Withdrawn |
| 5301-3513 | Outer Diameter 3.5 mm | Withdrawn |
| 5386-1608-S | Lordotic Angle 6 Deg | Withdrawn |
| 5301-3820 | 3.8mm Diameter, 20mm Length, No. 8 Hexalobe | Withdrawn |
| 5366-1411-N | Lordotic Angle 6 Deg | Withdrawn |
| 5302-3818 | Length 18 mm | Withdrawn |
| 5910-1002 | Withdrawn | |
| 5210-1010 | Length 10 in | Withdrawn |
| 5060-1411 | Width 16 mm | Withdrawn |
| 5380-1612 | Height 12 mm | Withdrawn |
| 5046-1205 | Height 5 mm | Withdrawn |
| 5340-1208 | Parallel | Withdrawn |
| 5346-1206-S | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1610-N | Parallel | Withdrawn |
| 5360-1410 | Height 10 mm | Withdrawn |
| 5066-1411 | Lordotic Angle 6 Deg | Withdrawn |
| 5386-1610-S | Lordotic Angle 6 Deg | Withdrawn |
| 5301-3820 | Length 20 mm | Withdrawn |
| 5340-1211 | Height 11 mm | Withdrawn |
| 5210-1022 | Length 10 in | Withdrawn |
| 5360-1411 | Height 11 mm | Withdrawn |
| 5340-1212 | Height 12 mm | Withdrawn |
| 5302-3814 | Outer Diameter 3.8 mm | Withdrawn |
| 5302-3516 | Length 16 mm | Withdrawn |
| 5366-1407-N | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1409-S | Height 9 mm | Withdrawn |
| 5346-1212-N | Height 12 mm | Withdrawn |
| 5380-1611-N | Height 11 mm | Withdrawn |
| 5046-1211 | Height 11 mm | Withdrawn |
| 5210-1010 | Length 10 in | Withdrawn |
| 5046-1210 | Height 10 mm | Withdrawn |
| 5060-1409 | Height 9 mm | Withdrawn |
| 5301-3514 | Outer Diameter 3.5 mm | Withdrawn |
| 5360-1412-S | Parallel | Withdrawn |
| 5340-1206-S | Height 6 mm | Withdrawn |
| 5386-1611-N | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1212-S | Parallel | Withdrawn |
| 5340-1209 | Height 9 mm | Withdrawn |
| 5346-1207-N | Lordotic Angle 6 Deg | Withdrawn |
| 5360-1408 | Parallel | Withdrawn |
| 5302-3518 | Length 18 mm | Withdrawn |
| 5360-1405-S | Parallel | Withdrawn |
| 5302-3820 | 3.8mm Diameter, 20mm Length, No. 8 Hexalobe | Withdrawn |
| 5346-1212 | Height 12 mm | Withdrawn |
| 5386-1607-S | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1409-N | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1036 | Length 8 in | Withdrawn |
| 5210-1007 | Length 10 in | Withdrawn |
| 5086-1611 | Height 11 mm | Withdrawn |
| 5302-3819 | 3.8mm Diameter, 19mm Length, No. 8 Hexalobe | Withdrawn |
| 5366-1406 | Height 6 mm | Withdrawn |
| 5302-3519 | Length 19 mm | Withdrawn |
| 5346-1209 | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5302-3514 | Length 14 mm | Withdrawn |
| 5346-1209-N | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1611-S | Parallel | Withdrawn |
| 5302-3815 | 3.8mm Diameter, 15mm Length, No. 8 Hexalobe | Withdrawn |
| 5360-1412-N | Height 12 mm | Withdrawn |
| 5360-1406-S | Height 6 mm | Withdrawn |
| 5210-1062 | Withdrawn | |
| 5346-1208 | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1015 | Length 6 in | Withdrawn |
| 5380-1609-N | Height 9 mm | Withdrawn |
| 5210-1016 | Length 6 in | Withdrawn |
| 5301-3515 | Standard Bone Screw | Withdrawn |
| 5380-1609-S | Parallel | Withdrawn |
| 5380-1608-S | Height 8 mm | Withdrawn |
| 5346-1211-S | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1205 | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1210-S | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1205 | Height 5 mm | Withdrawn |
| 5910-1001 | Length 21 in | Withdrawn |
| 5346-1209-S | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1210-N | Height 10 mm | Withdrawn |
| 5386-1605-S | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1606-N | Height 6 mm | Withdrawn |
| 5360-1408 | Height 8 mm | Withdrawn |
| 5340-1205 | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5210-1029 | Length 10 in | Withdrawn |
| 5210-1065 | Withdrawn | |
| 5386-1609 | Lordotic Angle 6 Deg | Withdrawn |
| 5386-1612 | Height 12 mm | Withdrawn |
| 5302-3517 | Length 17 mm | Withdrawn |
| 5060-1407 | Height 7 mm | Withdrawn |
| 5366-1408-S | Lordotic Angle 6 Deg | Withdrawn |
| 5360-1409-S | Height 9 mm | Withdrawn |
| 5040-1209 | Width 14 mm | Withdrawn |
| 5360-1412 | Parallel | Withdrawn |
| 5301-3819 | Length 19 mm | Withdrawn |
| 5040-1211 | width(MLxAP), 14 x 12, mm | Withdrawn |
| 5380-1608-N | Height 8 mm | Withdrawn |
| 5380-1605 | Height 5 mm | Withdrawn |
| 5301-3819 | 3.8mm Diameter, 19mm Length, No. 8 Hexalobe | Withdrawn |
| 5301-3814 | Length 14 mm | Withdrawn |
| 5366-1411-S | Height 11 mm | Withdrawn |
| 5066-1407 | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1206 | Height 6 mm | Withdrawn |
| 5386-1612-S | Lordotic Angle 6 Deg | Withdrawn |
| 5386-1608-N | Height 8 mm | Withdrawn |
| 5380-1612 | Height 12 mm | Withdrawn |
| 5380-1611 | Depth 16 mm | Withdrawn |
| 5302-3813 | 3.8mm Diameter, 13mm Length, No. 8 Hexalobe | Withdrawn |
| 5360-1409 | Parallel | Withdrawn |
| 5210-1066 | Withdrawn | |
| 5366-1409 | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1610-S | Parallel | Withdrawn |
| 5302-3819 | 3.8mm Diameter, 19mm Length, No. 8 Hexalobe | Withdrawn |
| 5301-3818 | Length 18 mm | Withdrawn |
| 5340-1210-N | Parallel | Withdrawn |
| 5060-1405 | Width 16 mm | Withdrawn |
| 5366-1412-N | Height 12 mm | Withdrawn |
| 5386-1610 | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1207-S | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1412-S | Lordotic Angle 6 Deg | Withdrawn |
| 5066-1409 | Height 9 mm | Withdrawn |
| 5360-1407 | Height 7 mm | Withdrawn |
| 5301-3515 | Outer Diameter 3.5 mm | Withdrawn |
| 5340-1209 | Height 9 mm | Withdrawn |
| 5301-3816 | Length 16 mm | Withdrawn |
| 5346-1210 | Lordotic Angle 6 Deg | Withdrawn |
| 5366-1410 | Lordotic Angle 6 Deg | Withdrawn |
| 5346-1208-N | Height 8 mm | Withdrawn |
| 5301-3813 | 3.8mm Diameter, 13mm Length, No. 8 Hexalobe | Withdrawn |
| 5346-1212-S | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1212 | Height 12 mm | Withdrawn |
| 5386-1607-N | Lordotic Angle 6 Deg | Withdrawn |
| 5080-1607 | Width 18 mm | Withdrawn |
| 5210-1045 | Length 10 in | Withdrawn |
| 5386-1608 | Height 8 mm | Withdrawn |
| 5910-1002 | Withdrawn | |
| 5302-3519 | 3.5mm Diameter, 19mm Length, No. 8 Hexalobe | Withdrawn |
| 5360-1408-N | Parallel | Withdrawn |
| 5360-1406 | width(MLxAP), 16 x 14, mm | Withdrawn |
| 5346-1211-N | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1211 | Parallel | Withdrawn |
| 5086-1605 | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1017 | Height 1 in | Withdrawn |
| 5302-3816 | Length 16 mm | Withdrawn |
| 5301-3517 | Standard Bone Screw | Withdrawn |
| 5366-1406-N | Lordotic Angle 6 Deg | Withdrawn |
| 5210-1006 | Length 10 in | Withdrawn |
| 5380-1612-N | Height 12 mm | Withdrawn |
| 5301-3817 | Length 17 mm | Withdrawn |
| 5301-3518 | Outer Diameter 3.5 mm | Withdrawn |
| 5366-1408 | Lordotic Angle 6 Deg | Withdrawn |
| 5340-1206 | Height 6 mm | Withdrawn |
| 5366-1410-N | Lordotic Angle 6 Deg | Withdrawn |
| 5380-1607 | Width 18 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
3 recalls name this product by its own identifiers, 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 |
| Titan Spine, LLC | 510(k) number | 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 |
| Titan Spine, LLC | 510(k) number | 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.