Strategic orthopaedic-related 510(k)s issued in May 2017

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

Locking Plate System* (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (Ivy Sports Medicine), Kirschner Wires* (Precifit Medical), SICAGE System* (Sicage), MALUC Total Hip Arthroplasty System (SurgTech)

To stay in touch with new and active players on the scene, let’s look closer at four clearances from this group: the locking plate, next-gen meniscus repair implant, SI joint device and new total hip.

Beijing KeYi Medical Device | Locking Plate System | K162380
Beijing, China

• Company’s first 510(k)
• For use in fixation for adult patients in ulna, radius, humerus, femur, tibia, fibula
• Titanium-based, provided unsterilized

Ivy Sports Medicine (acquired by Stryker) | Collagen Meniscus Implant (CMI) XL | K170364
Redwood City, CA, USA (Manufacturing facility)

• CMI remains the only collagen scaffold for meniscus repair and reinforcement that has been cleared for sale in the U.S. Its first implantation occurred in 4Q15; the company was acquired by Stryker within twelve months
• CMI XL has the same intended use and technological characteristics as the predicate, ReGen Collagen Scaffold (K082079), except for physical dimensions and mass—neither of which raised new questions of safety or effectiveness
• The difference from predicate is that XL’s height is ~12.5% greater, to better match the height of the native meniscus rim in patients whose needs are not met by two existing sizes of the device
• Other technologies under development for the meniscal repair market include Active Implants’ NUsurface polymer-based investigational treatment for persistent knee pain following medial meniscus surgery, Novopedics’ Meniscofix and Orthonika’s MenisciKnit, a novel synthetic total knee meniscus replacement

Sicage | SICAGE Bone Screw System | K170475
Sioux Falls, SD, USA

• Company’s first 510(k)
• The fully-threaded titanium alloy SICAGE bone screw is sold sterile and includes implants and instruments to treat sacroiliac (SI) joint disruptions and degenerative sacroiliitis
• Sicage enters this SI repair niche of the spine market alongside players such as Camber Spine, CoreLink, Life Spine, SI-BONE, SpineFrontier, Xtant Medical, Zyga Technology, etc.

SurgTech | MALUC Total Hip Arthroplasty System | K162125
Westlake, OH, USA

• We’ve previously noted Surgtech’s spine and trauma clearances; this is their first joint recon device
• MALUC comprises monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX delta femoral heads, uncemented acetabular shells and conventional polyethylene liners
• Primary predicate device was DePuy’s Summit, with secondaries including Stryker’s Exeter, Accolade, Trident and DePuy’s Pinnacle device with GVF liner

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.