LWJ · Class II · 21 CFR 888.3360

FDA Product Code LWJ: Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

Leading manufacturers include Plus Orthopedics, Osteonics Corp. and Stelkast Company.

81
Total
81
Cleared
144d
Avg days
1984
Since
81 devices
25–48 of 81
Cleared Dec 04, 2000
ACETABULAR PLATES
K002941
Encore Orthopedics, Inc.
Orthopedic · 74d
Cleared Nov 15, 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 28, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796
Stelkast Company
Orthopedic · 21d
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
K002141
Exactech, Inc.
Orthopedic · 30d
Cleared Aug 07, 2000
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471
Implex Corp.
Orthopedic · 88d
Cleared Jul 27, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745
Stelkast Company
Orthopedic · 49d
Cleared Jul 25, 2000
SL-PLUS AND SLR-PLUS STEMS
K001942
Plus Orthopedics
Orthopedic · 29d
Cleared May 04, 2000
MODULAR-PLUS REVISION STEM
K994126
Plus Orthopedics
Orthopedic · 149d
Cleared Nov 16, 1999
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 18, 1997
LATERAL FLARE INTERNAL COLLAR (LFIC)
K971900
Pro-Lfic, LLC
Orthopedic · 209d
Cleared Nov 13, 1997
PLUS EPF ACETABULAR CUP
K972931
Hhl Consulting
Orthopedic · 97d
Cleared Nov 13, 1997
PLUS-FIT ACETABULAR CUP
K973077
Plus Orthopedics
Orthopedic · 87d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178
Encore Orthopedics, Inc.
Orthopedic · 199d
Cleared Oct 24, 1996
PERFECTA REVISION HIP SYSTEM
K955553
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Oct 23, 1996
SC, CEMENTLESS HIP SYSTEM
K962034
Artos Medical Products GmbH
Orthopedic · 152d
Cleared Oct 23, 1996
CHROME COBALT BALL HEAD
K962268
Artos Medical Products GmbH
Orthopedic · 132d
Cleared Oct 08, 1996
DELTA HIP PROSTHESIS
K961378
Zimmer, Inc.
Orthopedic · 181d
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633
Encore Orthopedics, Inc.
Orthopedic · 230d
Cleared Oct 01, 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155
Intermedics Orthopedics
Orthopedic · 57d
Cleared Aug 08, 1996
SRRS PRESSED FIT FEMORAL REVISION COMPONENT
K960908
Stelkast Company
Orthopedic · 156d
Cleared Feb 15, 1996
INTERMOORE FRACTURE HIP STEM
K954854
Intermedics Orthopedics
Orthopedic · 115d
Cleared Feb 14, 1996
LFIC OR FETTO HIP
K952776
Zimmer, Inc.
Orthopedic · 243d
Cleared Jan 17, 1996
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
K953268
Stelkast Company
Orthopedic · 188d