Panels › Orthopedic › Product code KWA · Class 3

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Regulation 888.3330

0510(k)s in 12 months (114 all time)

0recalls in 12 months (203 all time)

198recalls that name a 510(k)

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Top companies in KWA

Company	510(k)s	Recalls
DePuy Orthopaedics, Inc.	12	88
Biomet, Inc.	11	67
Zimmer GmbH	9	24
Wrightmedicaltechnologyinc	26	0
Wright Medical Technology Inc	0	16
Biomet Manufacturing Corp	14	0
Encore Medical Corporation	6	2
Zimmer Biomet, Inc.	0	6
Protek, Inc.	4	0
Advanced Biosearch Assn.	3	0

Date	Firm and product	Code	Linked 510(k)
Jul 21, 2014	DePuy Orthopaedics, Inc. RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the D Terminated	KWA	K102080
Jul 21, 2014	DePuy Orthopaedics, Inc. RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation Terminated	KWA	K102080
Oct 25, 2013	Zimmer, Inc. Metasul Head. Intended for use either with or without bone cement in total hip arthroplasty. Terminated	KWA	K091973
Nov 27, 2012	Biomet, Inc. Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascula Terminated	KWA	K070274
Nov 21, 2012	Biomet, Inc. Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a f Terminated	KWA	K050124
Nov 6, 2012	Zimmer, Inc. Kopf Adapter S Sterile, Rx Terminated	KWA	K053536
Nov 6, 2012	Zimmer, Inc. Fitmore" Hip Stem Terminated	KWA	K071723
Nov 6, 2012	Zimmer, Inc. Metasul LDH Head Rx Sterile Terminated	KWA	None listed
Aug 16, 2012	Zimmer, Inc. 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) Terminated	KWA	K060704
Aug 16, 2012	Zimmer, Inc. 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) or 6 Terminated	KWA	K060704
Aug 16, 2012	Zimmer, Inc. 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65 Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) o Terminated	KWA	K060704
Aug 16, 2012	Zimmer, Inc. Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) or 65 ( Terminated	KWA	K060704
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Feb 14, 2012	Wright Medical Technology Inc DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular sh Terminated	KWA	K082924
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116076, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116072, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116070, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116068, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116066, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060, Biomet Orthopedics, Warsaw, IN. Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116058, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116052, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, REF 16-116048, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc A Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-116046, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc Ac Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented use, sterile, REF 16-104170, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, sterile, REF 16-104166, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104164, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104162, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104160, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104158, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235
Jun 8, 2011	Biomet, Inc. Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringl Terminated	KWA	K093235

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