FDA product code MBL: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
MBL is the FDA product code for prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel. FDA has cleared 13 510(k) submissions under MBL, from 5 different applicants. The average 510(k) review took 152 days (median 90). FDA has posted 12 recalls for MBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class II |
| Regulation | 21 CFR 888.3358 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 66 |
| 2020 | 1 | 106 |
| 2021 | 1 | 481 |
Compare with all 510(k) review times · Search every MBL clearance
Top MBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 9 | 2020-10-06 |
| Microport Orthopedics, Inc. | 1 | 2021-08-24 |
| Wrightmedicaltechnologyinc | 1 | 2012-10-22 |
| Smith & Nephew Richards, Inc. | 1 | 1996-03-27 |
| Arthronics, Inc. | 1 | 1994-03-28 |
Most recent MBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201157 | Microport Orthopedics, Inc. | Prime BIOFOAM® Multi-Hole Shells | 2021-08-24 | 481 |
| K201701 | Smith & Nephew, Inc. | R3 HA Coated Acetabular Shells | 2020-10-06 | 106 |
| K182535 | Smith & Nephew, Inc. | R3 Anteverted Liners | 2018-11-19 | 66 |
| K161233 | Smith & Nephew, Inc. | OXINIUM DH Fermoral Heads | 2016-12-14 | 226 |
| K122382 | Wrightmedicaltechnologyinc | DYNASTY BIOFOAM SHELL | 2012-10-22 | 77 |
Recalls for MBL devices
12 product recalls in 5 recall events; 0 initiated in the last five years and 6 still open. Most recent: 2020-04-22.
| Year | Recalls |
|---|---|
| 2020 | 6 |
Frequently asked questions
What is FDA product code MBL?
MBL is the FDA product code for prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel.
What device class is MBL?
Class II, regulation 21 CFR 888.3358. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBL?
Across 13 cleared submissions the average was 152 days from receipt to decision (median 90).
Which companies have the most MBL clearances?
Smith & Nephew, Inc. (9); Microport Orthopedics, Inc. (1); Wrightmedicaltechnologyinc (1); Smith & Nephew Richards, Inc. (1); Arthronics, Inc. (1).
Have MBL devices been recalled?
Yes: 12 product recalls across 5 recall events; the most recent began 2020-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MBL
- Run a recall and safety report across every MBL manufacturer
- Watch product code MBL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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