JDI · Class II · 21 CFR 888.3350

FDA Product Code JDI: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Cemented hip replacement has decades of clinical evidence supporting its durability. FDA product code JDI covers cemented semi-constrained hip prostheses with metal and polymer bearing surfaces.

These implants use bone cement — typically polymethylmethacrylate — to fix the femoral stem and acetabular component to the surrounding bone. Cemented fixation provides immediate stability and is preferred in elderly patients with poor bone quality.

JDI devices are Class II medical devices, regulated under 21 CFR 888.3350 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Biomet, Inc., Depuy, Inc. and Howmedica Corp..

565
Total
565
Cleared
125d
Avg days
1977
Since
565 devices
73–96 of 565
Cleared Mar 11, 2004
ATH FEMORAL STEM
K034028
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Oct 15, 2003
SC TOTAL HIP SYSTEM
K031474
Orthopedic Alliance, LLC
Orthopedic · 159d
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867
Eska Implants GmbH
Orthopedic · 187d
Cleared Aug 29, 2003
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396
Biomet, Inc.
Orthopedic · 17d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766
Smith & Nephew, Inc.
Orthopedic · 136d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734
Biomet, Inc.
Orthopedic · 27d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165
Plus Orthopedics
Orthopedic · 53d
Cleared Apr 01, 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153
Zimmer, Inc.
Orthopedic · 75d
Cleared Mar 04, 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265
Zimmer, Inc.
Orthopedic · 36d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646
Exactech, Inc.
Orthopedic · 14d
Cleared Oct 17, 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jul 25, 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094
Biomet, Inc.
Orthopedic · 28d
Cleared Jul 23, 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared May 28, 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380
Biomet, Inc.
Orthopedic · 27d
Cleared May 21, 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178
Plus Orthopedics
Orthopedic · 29d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989
Howmedica Osteonics Corp.
Orthopedic · 30d