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
49–72 of 81
Cleared Jul 28, 1989
GRIPPER II ACETABULAR CUP
K893584
Joint Medical Products Corp.
Orthopedic · 80d
Cleared Jun 08, 1989
CTI II STRAIGHT STEM
K891539
Orthopedic Systems, Inc.
Orthopedic · 83d
Cleared Jun 06, 1989
KDG ACETABULAR COMPONENT
K891262
Osteonics Corp.
Orthopedic · 90d
Cleared Feb 08, 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661
Depuy, Inc.
Orthopedic · 166d
Cleared Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921
Osteonics Corp.
Orthopedic · 27d
Cleared Oct 06, 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983
Howmedica Corp.
Orthopedic · 147d
Cleared Jun 29, 1988
CORIN MODULAR MOORE STEM
K881288
Orthopedic Systems, Inc.
Orthopedic · 93d
Cleared Apr 22, 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088
Joint Medical Products Corp.
Orthopedic · 469d
Cleared Nov 02, 1987
TI-FIT TOTAL HIP SYSTEM
K873797
Richards Medical Co., Inc.
Orthopedic · 45d
Cleared Jan 27, 1984
MICRO-STRUCTURED HS2P HIP STEMS
K833970
Osteonics Corp.
Orthopedic · 72d