FDA 510(k) Review: 2019 Additively-Manufactured Product Clearances

While walking the exhibit hall at the North American Spine Society Annual Meeting in September, we saw additively-manufactured implants on display at nearly every spine company’s booth. That observation, along with requests from readers who seek to identify new additive players, drove us to pull a list of FDA 510(k)-cleared products from 2019. Most of the recently cleared products are spine-related, as can be seen in the list below. Of note, two companies entered the additive space this year with their very first orthopedic-related 510(k)s: Additive Implants and Addivation Medical.

4WEB Medical | Cervical Spinal Truss System Stand Alone (CSTS-SA), K190870

• Submitted April 2019, granted August 2019
• Primary predicate: 4WEB CSTS, K173159
• Manufacturing process creates a hierarchical surface roughness with features that span from the macro to nano scale
• Design allows fixation screws to be placed through the truss implant and into adjacent vertebral bodies, creating a zero-profile stand-alone construct
• Features a single-step locking mechanism
• Sterile-packed

4WEB Medical | Hammertoe Truss System (HTS), K190926

• Submitted April 2019, granted July 2019
• Primary predicate: Additive Orthopaedics’ Hammertoe Correction System, K160264
• For fixation of osteotomies and reconstruction of the lesser toes following correction procedures (hammertoe, claw toe, mallet toe)
• Cannulated implants in HTS can be used with K-wires to deliver implants or temporarily stabilize outlying joints
• Sterile-packed

Additive Implants | SureMAX Cervical Spacer, K182477

• Submitted September 2018, granted January 2019
• Primary predicate: K2M Cascadia Interbody System, K160125
• Cervical spacer to be used with supplemental fixation; hyperlordotic implants to be used with an anterior cervical plate
• Implants designed for use with autogenous and/or allogeneic bone graft
• Roughened porous surface and features on superior, inferior and lateral aspects to engage bone with vertebral endplates
• Delivered in a single modular implant tray
• First orthopedic-related 510(k) for the company

Additive Orthopaedics | Patient Specific 3D Locking Lattice Plates, K183011

• Submitted October 2018, granted January 2019
• Primary predicate: Additive Orthopaedics’ Locking Lattice Plates, K170214
• Designed to address stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle
• Locking Lattice Plates and Patient Specific 3D Printed Bone Segments form the cornerstone of Game Plan™, a cloud-based, integrated surgical planning system that can move a product from CT scan to patient-specific implant in 2-4 weeks

Addivation Medical | Cervical Interbody System, K190291

• Submitted February 2019, granted July 2019
• Primary predicate: Stryker Tritanium C Anterior Cervical Cage, K171496
• To be used with autogenous bone graft and/or allogenic bone graft and implanted via an open, anterior approach
• To be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine
• First orthopedic-related 510(k) for Addivation Medical
• About the company: General Manager’s industry experience includes upper management roles at Additive Orthopaedics, Zimmer Biomet; product management at Stryker

Camber Spine Technologies | SPIRA Open Matrix ALIF and LLIF, K190483

• Submitted February 2019, granted September 2019
• Primary predicates: SPIRA Open Matrix ALIF (K162986) and LLIF (K180724)
• Systems to be used with supplementary fixation and autogenous or allogenic bone graft
• SPIRA technology features 3D-printed open architecture and roughened titanium arches to promote bone growth
• Submission adds allogenic bone graft indication to both systems first cleared under the predicates; the company announced its SCYLLA allogeneic bone matrix product in August 2019

ChoiceSpine | Hawkeye Vertebral Body Replacement, K183588

• Submitted December 2018, granted February 2019
• Primary predicate: ChoiceSpine Hawkeye Vertebral Body Replacement, K171686
• Submission adds cervical indication to system that was previously cleared for the thoracolumbar spine

DePuy Synthes | EIT Cellular Titanium Lumbar Cage – T/PLIF, K183447

• Submitted December 2018, granted February 2019
• Primary predicate: Stryker Tritanium PL Cage, K181014, with additional predicate EIT Cellular Titanium Lumbar Cage – PLIF, K172888
• For use with supplemental fixation and autogenous bone graft
• Submission expands labeling of the previously cleared K172888 devices to include a TLIF surgical approach, and to correct the raw material specification from ASTM F136 Alloy to ASTM F3001
• Johnson & Johnson acquired EIT in 3Q18, and released the CONDUIT interbody platform based on 3D-printed EIT Cellular Titanium Technology in 3Q19

Innovasis | AXTi Titanium Stand-Alone ALIF System, K182139

• Submitted August 2018, granted June 2019
• Primary predicate: Innovasis Ax Stand-Alone ALIF, K162236
• Titanium implants with an open geometric Tetracell Technology structure
• Implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation
• Interior to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft

Kalitec Medical | TiWAVE-L Porous Titanium Lumbar Cage, K182210

• Submitted August 2018, granted January 2019
• Primary predicate: HT Medical NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, K170318
• To be used with autogenous bone graft and/or allograft and implanted via a transforaminal or an open posterior approach, with supplemental fixation
• The company’s second additively manufactured device, following an application for the cervical spine

Nexxt Spine | NEXXT MATRIXX Stand Alone Cervical System, K190546

• Submitted March 2019, granted May 2019
• Primary predicate: Spinal Elements Vertu, K181837
• Indicated for use with autograft and/or allogeneic bone graft as an adjunct to fusion, implanted via an open, anterior approach, with provided bone screw fixation
• Company’s line of 3D-printed cellular titanium scaffold devices with tailored surface topology includes designs for cervical, TLIF, TLIF Oblique and vertebral body replacement applications

Stryker | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, K183249

• Submitted November 2018, granted July 2019
• Primary predicate: Stryker AVS PL Spacers, K151726
• This submission introduces an expandable posterior lumbar cage to the company’s Tritanium lineup
• The solid and porous structures are simultaneously built using Laser Rapid Manufacturing

Zavation | Ti3Z Cervical Interbody System, K191354

• Submitted May 2019, granted September 2019
• Primary predicate: Zavation Interbody Fusion System, K181246
• For use with autogenous bone graft at one level with supplemental fixation
• Features a porous internal body with an outer solid, roughened surface designed to engage with vertebral body end plates
• Porous and solid aspects of each implant are printed simultaneously
• Previous Ti3Z devices for lumbar applications available in five configurations: ALIF, LLIF, TLIF, T-PLIF and PLIF

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