FDA product code MAY: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
MAY is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under MAY, from 4 different applicants. The average 510(k) review took 112 days (median 78). FDA has posted 19 recalls for MAY devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class II |
| Regulation | 21 CFR 888.3353 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MAY clearance
Top MAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 1 | 2013-08-16 |
| Stryker Corp. | 1 | 2011-05-25 |
| Biomet, Inc. | 1 | 2009-02-11 |
| Portland Orthopaedics Pty. , Ltd. | 1 | 2005-10-07 |
Most recent MAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123604 | Howmedica Osteonics Corp. | ABG III MONOLITHIC HIP STEM | 2013-08-16 | 268 |
| K110807 | Stryker Corp. | ABG II MONOLITHIC HIP STEM | 2011-05-25 | 63 |
| K090103 | Biomet, Inc. | 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL | 2009-02-11 | 27 |
| K051844 | Portland Orthopaedics Pty. , Ltd. | EQUATOR PLUS ACETABULAR CUP SYSTEM | 2005-10-07 | 92 |
Recalls for MAY devices
19 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-21.
Frequently asked questions
What is FDA product code MAY?
MAY is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel.
What device class is MAY?
Class II, regulation 21 CFR 888.3353. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAY?
Across 4 cleared submissions the average was 112 days from receipt to decision (median 78).
Which companies have the most MAY clearances?
Howmedica Osteonics Corp. (1); Stryker Corp. (1); Biomet, Inc. (1); Portland Orthopaedics Pty. , Ltd. (1).
Have MAY devices been recalled?
Yes: 19 product recalls across 2 recall events; the most recent began 2016-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MAY
- Run a recall and safety report across every MAY manufacturer
- Watch product code MAY 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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