Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner

Q: What is the product code of K082924?

The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.

FDA 510(k) K082924 · Wrightmedicaltechnologyinc

Substantially Equivalent

510(k) numberK082924

Submission

Device name: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner
Applicant: Wrightmedicaltechnologyinc
Arlington, TN, US
Received: October 1, 2008
Decision date: March 6, 2009
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class III (high risk)
Regulation: 21 CFR 888.3330
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KWA

510(k)	Device	Applicant	Decision
K122778	Profemur Z Revision Hip StemKWA · Special	Wrightmedicaltechnologyinc	10/11/2012SE
K121544	Dynasty Biofoam ShellKWA · Traditional	Wrightmedicaltechnologyinc	07/30/2012SE
K113271	Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional	Biomet Manufacturing, Inc.	05/18/2012SE
K113322	Conserve Thin ShellKWA · Special	Wrightmedicaltechnologyinc	02/03/2012SE
K112080	Preserve Hip StemKWA · Special	Wrightmedicaltechnologyinc	12/28/2011SE
K112150	Profemur Gladiator Ha Hip StemKWA · Traditional	Wrightmedicaltechnologyinc	11/23/2011SE
K113019	Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special	Wrightmedicaltechnologyinc	11/10/2011SE
K111910	Gladiator Hip StemKWA · Traditional	Wrightmedicaltechnologyinc	10/14/2011SE
K110836	CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional	Zimmer GmbH	10/07/2011SE
K110400	Taperloc Complete Microplasty StemKWA · Traditional	Biomet Manufacturing Corp	09/30/2011SE

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Questions and answers

When was Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner cleared by the FDA?

Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner (K082924) received a 510(k) decision of Substantially Equivalent on March 6, 2009, 156 days after the submission was received.

What is the product code of K082924?

The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.