510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MBHClass II

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

21 CFR 888.3565 / Orthopedic
FDA source (opens on fda.gov)

MBH is the FDA product code for Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a class II device type, regulated under 21 CFR 888.3565. As of , FDA records hold 144 510(k) clearances under this code, the most recent dated , and 102 recalls.

Classification record

Product code
MBH
Device name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
146
Ingested recalls
103

Clearances, product code MBH

By decision year
146 clearances under product code MBH with a decision year between 2003 and 2026, 2007 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code MBH by decision year
YearClearances
20037
20048
20054
20068
200710
20083
20093
20104
20115
20125
20136
20149
20158
20164
20174
20186
20191
20207
20216
20227
20236
202410
20258
20267

Applicants with the most clearances

Product code MBH
Applicants holding the most 510(k) clearances under product code MBH
ApplicantClearances
Zimmer GmbH27
Smith & Nephew, Inc.11
Howmedica Osteonics Corp9
Wrightmedicaltechnologyinc8
Microport Orthopedics Inc.7
Biomet Manufacturing Corp6
Depuy Ireland UC6
Exactech, Inc.5
Stryker Orthopaedics5
Arthrex GmbH4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 179 companies shown, in name order