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FDA 510(k) Recap: Spine Company Clearances

Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list of new products each year. In this month’s recap we focus on small spine companies (portfolios under $100 million) that have received three or more FDA 510(k) clearances for spine products thus far in 2020.

Two smaller companies, CarboFix Orthopedics and Cutting Edge Spine, each received three clearances for products that use proprietary materials.

Life Spine and Medacta continued to build out their robust portfolios, while Nexxt Spine gained the majority of its clearances for additions to 3D-printed MATRIXX family of products.

Finally, SeaSpine racked up the most clearances with seven on the books to date, since January.

Of note, the majority of these clearances were granted within a short timeframe, including three within the month of submission (Life Spine, Nexxt Spine, SeaSpine).

CarboFix Orthopedics

  • CarboClear Lumbar Cage System, K193378 - Submitted April 2020, granted June 2020
  • CarboClear II Pedicle Screw System, K20051 - Submitted March 2020, granted April 2020
  • CarboClear Cervical Plate System, K200883 - Submitted December 2019, granted March 2020

Reported benefits of CarboClear material, which comprises continuous carbon fiber-reinforced polymer, include no backscattering, which allows the use of radiation therapy without harming the healthy surrounding tissue; minimal attenuation of External Beam Radiation, allowing radiation to pass through the implant with almost no reduction in the radiation dose level; and no artifact in CT.

Cutting Edge Spine

  • EVOL Spinal Interbody System, K20099 - Submitted April 2020, granted May 2020
  • EVOS Lumbar Interbody System, K20055 - Submitted March 2020, granted April 2020
  • EVOL ha - D Lateral Interbody Fusion System, K192497 - Submitted September 2019, granted January 2020

EVOL/EVOS devices are made of PEEK-OPTIMA HA (hydroxyapatite) Enhanced material from Invibio Biomaterial Solutions. Cutting Edge Spine implants made with this material have demonstrated early onset bone formation and apposition to its implants.

The company seeks to build the largest worldwide bioactive interbody fusion system portfolio.

Life Spine

  • ARx Spinal System, Implant and Instrument Additions, K20007 - Submitted January 2020, granted April 2020
  • ProLift Lateral Fixated, K200338 - Submitted February 2020, granted April 2020
  • Solstice CCI Posterior Cervical Screw, K200896 - Submitted April 2020, granted by month’s end
  • Steerable Plateau Ti, K193521 - Submitted December 2019, granted February 2020
  • ProLift Expandable System, K193258 - Submitted November 2019, granted January 2020

Life Spine plans to launch 20 new products in 2020, including six Micro Invasive Expandables.

Medacta

  • Mecta-C Stand Alone, K192906 - Submitted October 2019, granted March 2020
  • MectaLIF Anterior Simple Intervertebral Fusion Device, K200048 - Submitted January 2020, granted March 2020
  • M.U.S.T. MINI Posterior Cervical Screws System, K200130 - Submitted January 2020, granted February 2020
  • M.U.S.T. Pedicle Screw System, K193365 - Submitted December 2019, granted January 2020

Alongside expansion of its implant portfolio, the company just launched its NextAR Augmented Reality based surgical platform. Initially for use with total knee arthroplasty, the technology will be extended to hip, shoulder and spine applications. NextAR is designed with Artificial Intelligence and Machine Learning to add efficiency and precision to pre-operative CT-based planning and analysis.

Nexxt Spine

  • NEXXT MATRIXX System ALIF and Lateral Lumbar Systems, K200969 - Submitted April 2020, granted May 2020
  • NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, K200543 - Submitted March 2020, granted by month’s end
  • NEXXT MATRIXX System, K193412 - Submitted December 2019, granted February 2020
  • NEXXT MATRIXX System, K193370 - Submitted December 2019, granted January 2020
  • TrellOss-L MPF, K192687 - Submitted September 2019, granted January 2020

The company’s first 510(k) for 3D-printed MATRIXX interbody devices and vertebral body replacements occurred in 2017. Over time, additional clearances addressed line extensions such as the Stand Alone Cervical System, Stand Alone Cervical-TL, a steerable TLIF interbody device, an anterior lumbar interbody fusion (ALIF) device, corpectomy devices, etc.

The implants are based on proprietary residue-free surface technology with varied porosity titanium architecture. Compared to conventional spine devices, the company claims that NEXXT MATRIXX implants exhibit up to 4x more surface area for bone formation and up to 2x more open pore volume.

SeaSpine

  • SeaSpine Meridian System, SeaSpine Regatta Lateral System, K200879 - Submitted April 2020, granted June 2020
  • Meridian Anterior Plate System Regatta Lateral Plate System, K200885 - Submitted April 2020, granted May 2020
  • SeaSpine Reef TH System, K193636 - Submitted December 2019, granted April 2020
  • SeaSpine Skipjack System, K193418 - Submitted December 2019, granted March 2020
  • NorthStar OCT Spinal System, K193615 - Submitted December 2019, granted March 2020
  • Daytona Small Stature Spinal System, K200381 (pictured)  - Submitted February 2020, granted by month’s end
  • Daytona Small Stature Growth Rod Conversion Set, K193224 - Submitted November 2019, granted February 2020

SeaSpine has committed to driving an aggressive launch schedule in 2020, despite the pandemic. The company’s plans include alpha launches for an articulating NanoMetalene with Reef Topography implant and anterior compression and disc preparation instruments; alpha launches of a hinged TLIF IBD with NanoMetalene and a suite of Explorer lordotic and parallel expanding interbodies; alpha launch of a Cervical Facet Fusion System and alpha launch of a suite of 3D-printed interbody devices developed in collaboration with restor3D.



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