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Year in Review

Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

Small companies around the world and across the orthopedic market segments continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or their first FDA 510(k) in a new market segment. No surprise, the majority of companies (71%) are headquartered in the U.S., and the crowded spine market represented the largest subsegment for 510(k)s. Exhibits 1 and 2 break out company geographies and market segments for products cleared.

 

Exhibit 1: Companies with First Orthopedic FDA 510(k) in 2018, by Country

THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT: 510(k)s in 2018


Exhibit 2: First Orthopedic FDA 510(k)s in 2018, by Market Segment

THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT - First 510(k)s in 2018

 

The companies and products mentioned below can be found throughout the chapters of the 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. We thought you may find it useful to see them presented in one list, too.
 



Joint Replacement

B-One Ortho  | Aliso Viejo, California, U.S. |  Total Hip

  • Cementless system comprising the Juveno Femoral Hip and the b-ONE Primary Acetabular System, compatible with b-ONE 12/14 Taper Femoral Heads

 

Beijing AK Medical | Beijing, China | A3 Total Knee

  • Cemented, posteriorly stabilized design

 

RootLoc | Seoul, South Korea | Acculoc Total Knee

  • Cemented, fixed bearing type with a posterior stabilized design and cruciate retained design

 



Spine

Absolute Advantage Medical | Fayetteville, North Carolina, U.S. | ACCUFUSE Cervical System

  • Intervertebral body fusion devices and cervical plates/screws
  • Materials are PEEK, tantalum and titanium alloy
  • Commercial launch expected in 2Q19

                                        

Advanced Research Medical (an Inspired Spine company) | Burnsville, Minnesota, U.S. | Lumbar Interbody Fusion System (OLLIF)

  • Single-use instruments and titanium alloy implants in 24 size configurations
  • Implanted via the Oblique Lateral Lumbar approach
  • System is provided non-sterile

 

Axis Orthopaedics | Soldotna, Alaska, U.S. | KASILOF Anterior Cervical Plate

  • Titanium alloy plates and screws
  • Plates are available in a variety of lengths, addressing up to three levels of fixation
  • Company portfolio also includes FDA-cleared TALKEETNA 5.5 Lumbar Pedicle Screw

 

Black Box Medical | Midland, Texas, U.S. | Stowe Pedicle Screw

  • Titanium alloy longitudinal rods, polyaxial screws and transverse connectors
  • This product development company offers small companies and spine distributors inexpensive turn-key 510(k) spinal approvals based on proven technology

 

Chiral Surgical | Mission Viejo, California, U.S. | Pedicle Screw System

  • Top-loading multi-component titanium alloy or cobalt chrome posterior spinal fixation system comprising pedicle screws, rods, nuts and a transverse connectors

 

ClearView Orthopedic Development | Irvine, California, U.S. | Leucadia AutoLok Pedicle Screw

  • Titanium alloy rods and screws
  • Not the first clearance for the Leucadia AutoLok screw, it is the first 510(k) for this company, which was formerly Phygen; original clearance for a Leucadia AutoLok device occurred in 2012
  • The subject system has undergone slight redesign of locking interfaces between the pedicle screw, the AutoLok pedicle screw head and the AutoLok set screw/locking nut to support maximum stability of the construct under worst case tolerances

 

Curiteva | Tanner, Alabama, U.S. | Sage Cervical Interbody Fusion System

  • Manufactured of biocompatible PEEK polymer
  • Tantalum radiopaque markers to optimize visibility and placement
  • Multi-directional aggressive teeth designed to prevent implant migration

 

FBC Device | Risskov, Denmark | FBC 921 (ALIF)

  • Two-piece fusion device allows for in situ adjustment from nine to 21 degrees before locking
  • Device articulation enables larger bone graft windows vs. expandable interbodies
  • Company has also developed Statur-L, a hybrid of fusion and non-fusion technology designed to reduce the number of implants needed in a procedure

 

GBS Commonwealth | Seoul, South Korea | JASPER Spinal Fixation System

  • Intended for use as a posterior pedicle screw fixation system or as an anterolateral fixation system
  • Materials are titanium alloy or CoCrMo alloy
  • Other products in portfolio that are not FDA-cleared include a variety of PEEK interbody fusion cages and the HUVEX Interspinous Process Fusion System

 

Innovasive (rebranded as Amplify Surgical) | Mission Viejo, California, U.S. | DualX Intervertebral Fusion Device

  • Titanium dual expanding interbody device for lumbar fusion; product launches by year-end
  • Can expand in two independent directions: laterally, then vertically with lordosis to support restoration of sagittal alignment
  • Designs address transforaminal, posterior and lateral lumbar interbody fusion

 

Jiangsu Trauhui Medical | Changzhou, China | Cellent Spinal Systems

  • Titanium alloy pedicle screws, pedicle hooks, rods, set screws, connectors and cross links
  • Feature a dual half-length thread intended to increase screw purchase

 

Legend Spine | Bethlehem, Pennsylvania, U.S. | STYLO Interbody Fusion Device

  • Materials are either PEEK radiolucent material with embedded tantalum x-ray markers or titanium alloy

 

Presidio Surgical | Alamo, California, U.S. | Viking Lumbar Polyaxial Screw

  • Polyaxial pedicle screw system with straight or pre-contoured crosslink to provide optimal supporting structure for the spinal bodies

 

Rubicon Spine | Sarasota, Florida, U.S. | Lumbar Interbody Fusion System

  • PEEK with tantalum markers
  • Cages of various lengths, widths and heights, to be used with supplemental fixation

 

SIJ Surgical | Raleigh, North Carolina, U.S. | Outlet Sacroiliac Joint Fusion System

  • Titanium alloy cannulated, fully threaded screws with double helix threads designed to be able to screw into pre-drilled bone; includes optional washers

 

SpineEX | Fremont, California, U.S. | Sagittae Lateral Lumbar Interbody

  • Materials are titanium and titanium alloy
  • Expandable design allows for increments of independent adjustable height and lordosis intra-operatively to achieve sagittal balance
  • Reduces the number of devices, instruments and time required for trialing, sizing and distracting during surgery

 

Spinemed | Vienna, Austria | Acron TLIF System

  • Minimally invasive system designed for a unilateral posterior transforaminal approach (TLIF)
  • PEEK implantable cages with tantalum markers and stainless steel surgical instruments, both general and system specific

 

Tenon Medical | San Ramon, California, U.S. | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

  • Developed as a less invasive alternative to traditional open posterior surgical SIJ fusion
  • Includes an Access Set, Drill/Delivery Accessory Set and an Extraction Set
  • Titanium implant consists of two hollow barrels connected by a bridge
  • Autologous bone graft is placed in the barrel of the implant to facilitate stabilization
  • Implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use

 

Vallum | Nashua, New Hampshire, U.S. | PeekPlus Interbody Fusion Device

  • PEEK interbody fusion device with a PEEKplus nanotextured surface, created with proprietary Accelerated Neutral Atom Beam technology
  • Reportedly the first FDA-cleared nanotextured surface on a PEEK interbody
  • PEEKplus is not a coating, is not porous and no chemicals are infused into the PEEK
  • Nanotexturing technology may be applied to any fully-manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties

 



Trauma

Cable Fix Medical | Hernando, Mississippi, U.S. | Impress SFS System

  • Stainless steel cerclage system

 

Diamond Orthopedic | Charlotte, North Carolina, U.S. | Bone Fixation Screws and Pins

  • Sterile packaged faceted bone screws in headless compression, cortex and cannulated screws; pins and guidewires
  • The clearance supports Diamond’s strategy to penetrate the orthopedic ambulatory surgery center market

 

ExoToe | Grimes, Iowa, U.S. | Bone Staple

  • Stainless steel staple for fracture and osteotomy fixation and joint arthrodesis of the foot in conjunction with k-wire fixation

 

F & A Foundation (dba Reign Medical) | Tulsa, Oklahoma, U.S. | Clench Compression Staple

  • Nickel/titanium alloy device
  • Indicated for fixation of fracture/osteotomy fixation and joint arthrodesis of the hand/foot, proximal tibial metaphysis osteotomy, hand/foot bone fragments and osteotomy fixation and joint arthrodesis, and fixation of small bone fragments throughout the body

 

Field Orthopaedics | Spring Hill, Queensland, Australia | Micro Screw System

  • Comprising a titanium alloy Micro Screw Kit and stainless steel alloy Pin and K-Wire Kit
  • Indicated for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm and fixation and stabilization of bone fractures or as guidance at insertion of implants into the skeletal system, respectively

 

IlluminOSS Medical | East Providence, Rhode Island, U.S. | IlluminOss Bone Stabilization System

  • Light-curable liquid monomer, contained within an expandable PET balloon catheter
  • To treat impending and actual pathological fractures of the humerus, radius and ulna resulting from metastatic bone disease

 

MiRus | Marietta, Georgia, U.S. | Aurora Bone Screw

  • Ti 6Al-4V ELI device for the repair of fractures, fusions, osteotomies of bones and bone fragments

 

Orthovestments | Marietta, Georgia, U.S. | Orbitum Bone Staple, X and VI

  • Ti 6Al-4V ELI device for fracture and osteotomy fixation and joint arthrodesis of the hand/foot

 

Panther Orthopedics | San Jose, California, U.S. | PUMA System

  • Nitinol-based flexible syndesmosis fixation device for various foot/ankle repair applications

 

SIG Medical | Hershey, Pennsylvania, U.S. | AdvantageRib Anterior System

  • Titanium locking bone plates and titanium alloy locking and non-locking screws
  • For fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

 

X-Bolt Orthopaedics | Santry, Dublin, Ireland | X-BOLT Hip Fracture Fixation System

  • Expanding bolt device for fracture fixation in the femur in adults with osteopenia or osteoporosis
  • 1,000th patient has completed one-year follow-up in WHITE4, a randomized controlled trial comparing X-BOLT vs. a sliding hip screw, the current standard of care in hip fracture treatment; at 1,140 subjects, this is the largest-ever trial comparing extracapsular hip fracture fixation devices

 



Sports Medicine

Aevumed | Wayne, Pennsylvania, U.S. | PHANTOM Suture Anchor with HS Fiber Suture

  • Threaded suture anchor manufactured from PEEK, preloaded on a disposable driver
  • Cleared for use in suture and soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow
  • Company is developing PHANTOM-X technology to address the 20% failure rate of rotator cuff surgeries by providing biomechanical support and biological enhancement

 

Arcuro Medical | Misgav, Israel | SuperBall Meniscal Repair System

  • Knotless all-suture anchor and delivery system
  • Entire procedure is performed inside the joint space using suture material only and requiring just one entry into the joint

 

IntraVu | Redwood City, California, U.S. | MIDAScope and Introducer Kit, MIDASystem Arthroscope

  • Disposable, micro-direct in-office visualization scope
  • Indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening
  • Reportedly has a 50% smaller surface area and is 30% cheaper than competitor products

 

Responsive Arthroscopy | Minneapolis, Minnesota, U.S. | Interference Screw

  • Indicated for the reattachment and fixation of tissue including ligament, tendon, soft tissue or bone to bone

 

SportWelding | Schlieren, Switzerland | Fiji Anchor

  • System comprises an implantable resorbable anchor, an ultrasound system, handpiece tip and a twist drill
  • BoneWelding employs ultrasonic energy to liquefy pre-defined polymeric components of the implant, forming a bond between implant and bone

 



Orthobiologic

Acro Biomedical | Kaohsiung City, Taiwan | ABCcolla Bone Graft

  • Resorbable porcine-based bone mineral matrix
  • Fills bony voids or gaps of the skeletal system (i.e., extremities and pelvis)
  • Product has also has obtained the Taiwan FDA Class II medical certificate

 

AgNovos Healthcare | Rockville, Maryland, U.S. | JGH1 Bone Graft Substitute, JGH1 Core Decompression Procedure Kit

  • Fills bony voids or gaps of the skeletal system (i.e., extremities and pelvis)
  • Product is also CE Marked

 

Cellumed | Seoul, South Korea | Rafugen DBM

  • Human bone allograft product containing demineralized bone matrix, carboxymethyl cellulose, starch and glycerol
  • Fills bony voids or gaps of the skeletal system (i.e., extremities and pelvis)

 

Elute | Salt Lake City, Utah, U.S. | EP Granules Bone Void Filler

  • Osteoconductive device comprising hydroxyapatite, calcium carbonate and calcium chloride particles bound together with a degradable polymer-based binding matrix of poly(caprolactone), poly(ethylene glycol) and poly(lactide-co-glycolide)
  • Fills bony voids or gaps of the skeletal system (i.e., extremities and pelvis)



Source: FDA.gov