Table 2. OTS implants which are additively manufactured that received FDA clearance. DDD implies for patients who presents with neck pain of discogenic origin and confirmed radiographically. Prior to surgery, all patients must be skeletally matured and received non-surgical treatment 6 weeks beforehand. All implants consist of a solid and an empty/porous structure to allow packing of bone graft.
| Implant name [510(K) number] | Date approved | Material; method of manufacturing | Indication | Level | Regulatory class | Available design | Use | Non-clinical performance testing summary |
|---|---|---|---|---|---|---|---|---|
| EIT Cellular Titanium® Cervical Cage (K170503) (46) | July 11, 2017 | Titanium alloy (Ti6Al4V); SLM | Single or two contiguous levels of cervical DDD | C2/C3–C7/T1 disc | II | Different heights, footprints and lordosis angles | Used with supplementary fixation cleared for the use in cervical spine | Static compression, static compression-shear, dynamic compression, dynamic compression-shear, static torsion, dynamic torsion, expulsion, and subsidence per ASTM F0277-14 and F2267-04 |
| Stryker Tritanium® C Anterior Cervical Cage (K171496) (47) (Figure 2) | September 6, 2017 | Titanium alloy (Ti6Al4V); SLM | Single or two contiguous levels of cervical DDD | C2/C3–C7/T1 disc | II | Different heights, footprints and lordosis angles | Used with supplementary fixation cleared for the use in cervical spine | Static compression, static compression-shear, dynamic compression, dynamic compression-shear, torsion and dynamic torsion per ASTM F0277; expulsion per ASTM F04-25-02-02 Draft; subsidence per ASTM F2267; wear debris assessment; and impaction |
| Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (K153250) (48) | March 16, 2016 | Cages are additively manufactured using titanium alloy (Ti6Al4V), bone screws manufactured from titanium alloy (Ti6Al4V) and cover plate assembly manufactured from titanium alloy (Ti6Al4V) and nitinol alloy | Single level cervical DDD | C2/C3–C7/T1 disc | II | The system includes the Tesera Trabecular Titanium (T3) cages, bone screws and anterior cover plate assembly. Different widths, heights, depths, and bone screw sizes | When used with cover plate and screws, the Tesera SC ACF system does not require supplementary fixation. If used without cover plate and screws, the Tesera SC ACF cages require supplementary fixation. | Static compression, static compression-shear, dynamic compression, dynamic compression-shear, static torsion and dynamic torsion per ASTM F0277-14; expulsion testing with and without screws per ASTM F04.25.02.02 Draft; subsidence without screws per ASTM F2267-04; and cover plate assembly corrosion per ASTM F2129-08 |
| 4Web Cervical Spinal Truss System (CSTS) Interbody Fusion Device (K173159) (49) | January 8, 2018 | Titanium alloy (Ti6Al4V) | Single or two contiguous levels of cervical DDD | C2/C3–C7/T1 disc | II | Different sizes | Must be used with supplementary fixation | Static compression, static compression-shear, dynamic compression, dynamic compression-shear, torsion and dynamic torsion per ASTM F0277; subsidence per ASTM F2267-04; MR image artifact per ASTM F2119; MR induced displacement force per ATSM F2052; MR induced Torque per ASTM F2213; MR induced heating per ASTM F2182; and expulsion testing |
| K2M Cascadia Interbody System (K160125) (50) | April 22, 2016 | Titanium alloy (ASTM standards F3001 and F136); SLM | Single or two contiguous levels of cervical DDD | C2/C3–C7/T1 disc | II | Different sizes and heights | Used with supplementary fixation cleared for the use in cervical spine; the hyperlordotic Cascadia cervical implants (≥10°) are required to be used with an anterior cercial plate | Static compression, static compression-shear, dynamic compression, dynamic compression-shear, torsion and dynamic torsion per ASTM F0277; subsidence per ASTM F2267; and expulsion |
| K2M CAPRI Cervical Corpectomy Cage System (K171704) | August 31, 2017 | No summary letter was provided by FDA. Hence no data could be elicited | ||||||
SLM, selective laser melting; DDD, degenerative disc disease.