ULNAR HEAD IMPLANT— 510(k) K010786

Clearance details

Applicant

Avanta Orthopaedics, Inc.

Product code

Code KXE

Device class

Class 2

Regulation

21 CFR 888.3810

Advisory panel

Orthopedic

Date received

2001-03-15

Decision date

2001-04-11

Decision

Substantially Equivalent

Clearance type

Special

Location

San Diego, CA, US

• K190599 — Aptis Medical Distal Radio Ulnar Joint Implant2019-05-03
• K142569 — Aptis Medical Distal Radio Ulnar Joint Implant2015-04-03
• K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT2012-04-09
• K081025 — ISOELASTICU2008-11-21
• K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT2008-10-24

• K030881 — AVANTA CARPAL FUSION PLATING SYSTEM2003-04-10
• K021859 — WRIST IMPLANT2002-12-02
• K023604 — MODIFICATION TO RADIAL HEAD IMPLANT2002-11-27
• K013629 — FINGER JOINT PROSTHESIS2002-01-25
• K010847 — K'FIX2001-06-19

• Z-0098-2014 — Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.Class II·Terminated·Small Bone Innovations, Inc.·20130906

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010786.