MBL
13 FDA 510(k) clearances · Product code
90 daysmedian time to decision
390 days90th percentile
13clearances measured
FDA profile
- Official device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 116 · 2022: 90 · 2023: 78 · 2024: 54 · 2025: 43 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Prime BIOFOAM® Multi-Hole Shells (K201157) | Microport Orthopedics, Inc. | 2021-08-24 |
| R3 HA Coated Acetabular Shells (K201701) | Smith & Nephew, Inc. | 2020-10-06 |
| R3 Anteverted Liners (K182535) | Smith & Nephew, Inc. | 2018-11-19 |
| OXINIUM DH Fermoral Heads (K161233) | Smith & Nephew, Inc. | 2016-12-14 |
| DYNASTY BIOFOAM SHELL (K122382) | Wrightmedicaltechnologyinc | 2012-10-22 |
| R3 XLPE LINERS (K113848) | Smith & Nephew, Inc. | 2012-04-27 |
| R3 XLPE ANTEVERTED LINERS (K102370) | Smith & Nephew, Inc. | 2011-01-19 |
| COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (K093363) | Smith & Nephew, Inc. | 2010-01-26 |
| R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (K092386) | Smith & Nephew, Inc. | 2009-11-03 |
| SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (K070756) | Smith & Nephew, Inc. | 2007-06-06 |
| REFLECTION 3 ACETABULAR SYSTEM (K061253) | Smith & Nephew, Inc. | 2006-05-31 |
| REFLECTION DUAL DIMENSION SHELL (K960094) | Smith & Nephew Richards, Inc. | 1996-03-27 |
| LOGYK ACETABULAR COMPONENT SYSTEM (K931107) | Arthronics, Inc. | 1994-03-28 |
Track MBL automatically
Every clearance here is in the API, with alerts when new ones post.