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..

564
Total
564
Cleared
125d
Avg days
1977
Since
564 devices
73–96 of 564
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
Cleared Apr 04, 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970
Biomet, Inc.
Orthopedic · 9d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291
Exactech, Inc.
Orthopedic · 30d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350
DePuy Orthopaedics, Inc.
Orthopedic · 29d