Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices

FDA released 56 orthopaedic-related 510(k)s in June 2017. Of these, we chose eight that fit our definition of strategic.¹ Of those, two represented the company’s first orthopaedic 510(k). These are marked with an asterisk, below.

Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System* (Phamedica); Total Hip (Responsive Orthopedics/Medtronic); Interbody Fusion System* (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)

Let’s focus on the hip devices and four of the spine products. Here are two total hips that we’ve been expecting, plus two companies growing their spine portfolios and two spine companies receiving their first U.S. device clearances ever.

Hips

ConforMIS | ITotal Hip Replacement System | K162719
Bedford, Massachusetts | conformis.com

• First hip product, limited launch slated for 2019 (Update, 8/7/17: launch has been accelerated to 2H18 per leadership)
• Supported by same iFit “Image-to-Implant” technology to manufacture cutting jigs and implants as is used to design custom knees
• iTotal hip employs single-use 3D printed instruments and just-in-time delivery
• Originally submitted hip application in 2015, but in light of an inability to address FDA’s review questions within an allowed review timeframe, withdrew the application and resubmitted in 2H16

Responsive Orthopedics/Medtronic | Total Hip Arthroplasty System | K163585
Columbia City, Indiana | medtronic.com

• Second product from Medtronic’s orthopaedic initiative (acquired in 2Q16 and launched in 4Q16); first product was the total knee
• Predicates include DePuy Summit Tapered Hip, Ortho Development Ovation Stem, Smith & Nephew REFLECTION, United Orthopedic U2 Acetabular/UTF Stem/U2 Femoral Head
• While no recent announcement has been made, at the time of acquisition, leadership noted potential U.S. availability of its primary hip in 1H18
• Per FY4Q17 call, expect to hear an update on Medtronic Orthopaedic Solutions this year (next quarterly report is scheduled for 8/22/17)

Spine

Nexus Spine | Tranquil Interbody System | K170297
Salt Lake City, Utah | nexusspine.com

• 3D-printed titanium cervical and lumbar systems
• Second FDA-cleared system, following the PressOn pedicle screw
• Has also developed the FLEXBAC cervical disc, not cleared in the U.S.

Phamedica | PHA S1 Spinal System | K163011
Plainview, New York

• First FDA 510(k); company founded in 2014
• System comprises titanium alloy polyaxial and monoaxial screws and reduction screws, rods, set screws, transverse/offset connectors

Spinal Analytics & Geometrical Implant | SAGICO Interbody Fusion | K161710
London, United Kingdom | sagico.eu

• First FDA 510(k)
• System includes ARIA lumbar and ARION cervical implants made from PEEK (from Invibio), titanium alloy (Dynamet) and tantalum beads/rods (X-medics)
• Per website, company’s full ex-U.S. range includes thoracolumbar fixation, anterior/posterior cervical, interbody fusion, biologics, vertebroplasty/kyphoplasty and cranial products with instrument sets

Vertera Spine | COALESCE Lumbar Interbody Fusion System | K163506
Atlanta, Georgia | verteraspine.com

• COALESCE includes devices for a variety of approaches: Straight, Convex, Crescent, Lateral, Anterior and Oblique
• Second FDA 510(k) clearance, following COHERE cervical interbody fusion
• Implants are PEEK-based and feature porous architecture on select faces, which is derived directly from the implant and is not sintered or added as a coating; this was also used on COHERE, which was the first FDA-cleared spine device to be manufactured entirely out of PEEK and contain porosity
• The material is reportedly more durable than metal coatings and 2x stronger under shear loading than trabecular bone

Sources: FDA 510(k) Releasable Database, company websites, information in the public domain

¹Defined, for instance, as a company’s first 510(k) clearance, first clearance in a segment that is new for that company, clearance for a type of device not formerly marketed by a company, etc.