Panels › Orthopedic › Product code MBL · Class 2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Regulation 888.3358
0510(k)s in 12 months (13 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in MBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 9 | 9 |
| Microport Orthopedics, Inc. | 1 | 1 |
| Ortho Development Corporation | 0 | 2 |
| Arthronics, Inc. | 1 | 0 |
| Smith & Nephew Richards, Inc. | 1 | 0 |
| Wrightmedicaltechnologyinc | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2021 | K201157 | Prime BIOFOAM® Multi-Hole Shells Microport Orthopedics, Inc. | MBL |
| Oct 6, 2020 | K201701 | R3 HA Coated Acetabular Shells Smith & Nephew, Inc. | MBL |
| Nov 19, 2018 | K182535 | R3 Anteverted Liners Smith & Nephew, Inc. | MBL |
| Dec 14, 2016 | K161233 | OXINIUM DH Fermoral Heads Smith & Nephew, Inc. | MBL |
| Oct 22, 2012 | K122382 | DYNASTY BIOFOAM SHELL Wrightmedicaltechnologyinc | MBL |
| Apr 27, 2012 | K113848 | R3 XLPE LINERS Smith & Nephew, Inc. | MBL |
| Jan 19, 2011 | K102370 | R3 XLPE ANTEVERTED LINERS Smith & Nephew, Inc. | MBL |
| Jan 26, 2010 | K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS Smith & Nephew, Inc. | MBL |
| Nov 3, 2009 | K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS Smith & Nephew, Inc. | MBL |
| Jun 6, 2007 | K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc. | MBL |
| May 31, 2006 | K061253 | REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc. | MBL |
| Mar 27, 1996 | K960094 | REFLECTION DUAL DIMENSION SHELL Smith & Nephew Richards, Inc. | MBL |
| Mar 28, 1994 | K931107 | LOGYK ACETABULAR COMPONENT SYSTEM Arthronics, Inc. | MBL |
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