FDA Product Code MBL: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
Leading manufacturers include Smith & Nephew, Inc., Wrightmedicaltechnologyinc and Microport Orthopedics, Inc..
13
Total
13
Cleared
152d
Avg days
1994
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous Devices (Product Code MBL)
13 devices
Cleared
Aug 24, 2021
Prime BIOFOAM® Multi-Hole Shells
Microport Orthopedics, Inc.
Orthopedic
481d
Cleared
Oct 06, 2020
R3 HA Coated Acetabular Shells
Smith & Nephew, Inc.
Orthopedic
106d
Cleared
Nov 19, 2018
R3 Anteverted Liners
Smith & Nephew, Inc.
Orthopedic
66d
Cleared
Dec 14, 2016
OXINIUM DH Fermoral Heads
Smith & Nephew, Inc.
Orthopedic
226d
Cleared
Oct 22, 2012
DYNASTY BIOFOAM SHELL
Wrightmedicaltechnologyinc
Orthopedic
77d
Cleared
Apr 27, 2012
R3 XLPE LINERS
Smith & Nephew, Inc.
Orthopedic
120d
Cleared
Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
Smith & Nephew, Inc.
Orthopedic
152d
Cleared
Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
May 31, 2006
REFLECTION 3 ACETABULAR SYSTEM
Smith & Nephew, Inc.
Orthopedic
27d
About Product Code MBL - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MBL since 1994, with 13 receiving FDA clearance (average review time: 152 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.