Most Options System

• • Terminated Z-1250-2014 FDA Class II ·initiated 25 Feb 2014

  A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

• • Terminated Z-0996-2009 FDA Unclassified (pre-2012) ·initiated 29 Jan 2009

  The package contains 11 mm screws instead of the specified 6 mm screws.

• • Terminated Z-0539-05 FDA Unclassified (pre-2012) ·initiated 17 Dec 2004

  Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

510(k) Number

K013031 ↗

FDA Product Code

KRO

Device Class

Class II

Regulation

21 CFR Part 888.3510

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →