FDA 510(k) Recap: Knees, Hips, Shoulders, Wrists and Elbow Joints

Of 44 products that received FDA 510(k) clearance under the orthopedic panel in May, half were spine devices and a little over a quarter were for joint replacement (27%). (The rest were trauma, 7 clearances; sports medicine, 2 and orthobiologics, 1.)

Despite the fact that spine devices always seem to garner the most clearances in any given month, joint replacement is the bread and butter for most of the diversified companies. This month, let’s focus on these products that rebuild knees, hips and extremities. Two are from companies receiving their first orthopedic-related clearance; most are from folks that you know.

Knee

MicroPort Orthopedics | K182251, EVOLUTION NitrX Medial-Pivot Knee

  • Submitted August 2018
  • Line extension of the EVOLUTION MP Total Knee
  • Manufactured from cobalt chrome alloy featuring a titanium niobium nitride coating to reduce the release of cobalt, chromium, nickel and molybdenum ions
  • TiNbN coating also reportedly lends increased hardness and wettability, enhanced wear properties, high corrosion resistance and excellent biocompatibility

Precision Casting Solutions | K190355, Total Knee System

  • First orthopedic 510(k) clearance
  • Submitted February 2019
  • For total and revision procedures, used with cement
  • Fixed bearing implant in posterior-stabilized and cruciate-retaining configurations
    • Company established in 2011, located in Oregon
  microport evolution medial pivot knee nitrx
 

MicroPort Orthopedics EVOLUTION NitrX Medial-Pivot Knee

  

   Medacta Masterloc
 

  
Medacta MasterLoc

   

  aptis druj sq
 

  
Aptis Medical DRUJ

   

  DePuy Delta XTEND rec
 

  
DePuy Synthes Delta Xtend Reverse Shoulder

  

Zimmer Biomet | K183583, Vanguard Complete Knee System

  • Submitted December 2018
  • Update to a previously cleared system; clearance is for a modification to the tibial bearings

 

Hip

Limacorporate | K181491, Delta Dual Mobility System

  • Submitted June 2018
  • Offering a dual mobility option for the Delta TT (Trabecular Titanium) Acetabular System

Medacta | K191145, MasterLoc Extension

  • Submitted April 2019
  • Line extension to the MasterLoc Stem
  • Offers two additional and larger sizes (13 and 14) for both the MasterLoc LAT and LAT Plus

Waldemar Link | K182321, MobileLink Acetabular Cup System

  • Submitted August 2018
  • Indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures
  • Press-fit titanium alloy shells, offered in two designs: cluster hole, with closing screws and a polar screw, and a multi-hole shell
  • Both available with plasma sprayed coating (PlasmaLink) or a double coating of plasma spray plus calcium phosphate coating (TiCaP)
  • Clearance does not include femoral components; compatible with previously cleared femoral heads, hip stems and neck segments

Zimmer Biomet | K182678, Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology

  • Submitted September 2018
  • Clearance relates to an update to the Instructions for Use to include magnetic resonance (MR) Conditional labeling within the precaution section; the device package label will also be updated to include the MR Conditional symbol

 

Extremities

Aptis Medical | K190599, Distal Radio Ulnar Joint Implant (DRUJ)

  • Submitted March 2019
  • Intended for replacement of the distal radio ulnar joint following ulnar head resection arthroplasty
  • Device originally cleared in 2005; additional stem lengths and diameters have been added over the years

DePuy Synthes | K183077, Delta Xtend Reverse Shoulder System

  • Submitted November 2018
  • Clearance relates to the addition of lateralized glenosphere components
  • System initially cleared in 2007; has received line extensions and additional indications since then

Ignite Orthopedics | K183618, Revolution Radial Head

  • First orthopedic 510(k) clearance
  • Submitted December 2018
  • One-piece, stemmed CoCrMo alloy radial head, indicated for primary and revision procedures
  • When more height is needed for stability, the system accepts in situ addition of a spacer without the need to exchange heads or dislocate the radius and remove the trial
  • Trials and spacers are radiolucent, allowing the surgeon to assess spacing of the entire elbow joint when selecting implant size
  • “Ready-Set Go” kit contains all implant sizes and sterile single-use instrumentation in one box
  • About the company:
    • Established in 2017 in Warsaw, Indiana
    • Product development and commercialization entity focused on shoulder and elbow replacement
    • Leadership has experience at Biomet, Tornier, Wright Medical, Zimmer

Vilex in Tennessee | K190543, Cannulated Hemi Implant

  • Submitted March 2019
  • One-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint
  • Company recently acquired by OrthoPediatrics


General Use

Heraeus Medical | K190766, PALACOS fast R+G Bone Cement

  • Submitted March 2019
  • Indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints
  • Contains gentamicin
  • Composed of the same materials as PALACOS R+G; however, the benzoyl peroxide content and monomer liquid:powder ratio have been modified to produce a cement with a shortened setting time compared to the PALACOS R+G formula


Sources: FDA.gov, company press releases, websites, information in the public domain



Julie A. Vetalice
is ORTHOWORLD’s Editorial Assistant.