Gmk Sphere Extension

510(k) Number

K140826 ↗

FDA product code

JWH

Device class

Class II

Regulation

21 CFR Part 888.3560

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

• Persona® 42-5860-071-15 by Zimmer, Inc.
• Persona® 42-5870-020-01 by Zimmer, Inc.
• All poly tibial component, CR 2203-1058 by UNITED ORTHOPEDIC CORP.
• PHYSICA KR Right Tibial Liner 6531.50.611 by Limacorporate
• GMK Sphere Total Knee System 02.12.E0517FL by Medacta International SA
• APEX Knee System EP-20513 by OMNIlife science, Inc.
• PHYSICA KR 6531.54.512 by Limacorporate
• Freedom PCK Components by MAXX ORTHOPEDICS INC.
• GMK Sphere Total Knee System 02.12.E0411CRL by Medacta International SA
• APEX Revision Knee KP-45050 by OMNIlife science, Inc.

• Versafitcup Cc Trio

  Class II

  FDA 510(k) K103352 Active Cleared 11 Feb 2011

• Mectalif

  Class II

  FDA 510(k) K131671 Active Cleared 5 Jul 2013

• Meta-C Cervical Plate

  Class II

  FDA 510(k) K140361 Active Cleared 12 Jun 2014

• Gmk Sphere

  Class II

  FDA 510(k) K121416 Active Cleared 20 Jul 2012

See all devices from Medacta International →