FDA product code MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MEH is the FDA product code for prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel. FDA has cleared 160 510(k) submissions under MEH, 17 in the last five years, from 58 different applicants. The average 510(k) review took 157 days (median 109); 113 days on average over the last three years. FDA has posted 197 recalls for MEH devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class II |
| Regulation | 21 CFR 888.3353 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 195 |
| 2018 | 2 | 187 |
| 2019 | 1 | 265 |
| 2020 | 3 | 158 |
| 2021 | 3 | 97 |
| 2022 | 3 | 159 |
| 2023 | 2 | 176 |
| 2024 | 6 | 104 |
| 2025 | 5 | 146 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every MEH clearance
Top MEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteonics Corp. | 24 | 1999-07-23 |
| Howmedica Osteonics Corp. | 19 | 2013-02-01 |
| Smith & Nephew, Inc. | 13 | 2017-05-01 |
| Exactech, Inc. | 8 | 2025-03-10 |
| Signature Orthopaedics Pty, Ltd. | 8 | 2024-11-25 |
53 more applicants have MEH clearances. See the full list in Caduvo.
Most recent MEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261576 | Corin, Ltd. | Icona Hip Stem | 2026-08-10 | 90 |
| K250375 | Waldemar Link GmbH & Co. KG | Allure Hip Stem and Intramedullary Plugs | 2025-11-05 | 268 |
| K251166 | Medacta International S.A. | Mfinity Femoral System | 2025-06-13 | 59 |
| K251052 | Ortho Development Corp. | Trivicta® Hip Stem | 2025-05-22 | 49 |
| K242315 | United Orthopedic Corporation | Resolve Modular Revision Hip Stem | 2025-05-01 | 269 |
Recalls for MEH devices
197 product recalls in 42 recall events; 3 initiated in the last five years and 6 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 15 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MEH?
MEH is the FDA product code for prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel.
What device class is MEH?
Class II, regulation 21 CFR 888.3353. Typical premarket route: 510(k).
How long does a 510(k) take for product code MEH?
Across 160 cleared submissions the average was 157 days from receipt to decision (median 109).
Which companies have the most MEH clearances?
Osteonics Corp. (24); Howmedica Osteonics Corp. (19); Smith & Nephew, Inc. (13); Exactech, Inc. (8); Signature Orthopaedics Pty, Ltd. (8).
Have MEH devices been recalled?
Yes: 197 product recalls across 42 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MEH
- Run a recall and safety report across every MEH manufacturer
- Watch product code MEH 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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