FDA product code LOD: Bone Cement
LOD is the FDA product code for bone cement. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. FDA has cleared 72 510(k) submissions under LOD, 8 in the last five years, from 24 different applicants. The average 510(k) review took 167 days (median 126); 105 days on average over the last three years. 8 PMA applications cite this product code. FDA has posted 36 recalls for LOD devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bone Cement |
| Device class | Class II |
| Regulation | 21 CFR 888.3027 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LOD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 116 |
| 2018 | 2 | 70 |
| 2019 | 4 | 121 |
| 2020 | 3 | 122 |
| 2021 | 4 | 128 |
| 2022 | 3 | 224 |
| 2023 | 2 | 417 |
| 2024 | 1 | 177 |
| 2025 | 1 | 20 |
| 2026 | 1 | 117 |
Compare with all 510(k) review times · Search every LOD clearance
Top LOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Heraeus Medical GmbH | 9 | 2024-12-05 |
| DePuy Orthopaedics, Inc. | 9 | 2008-05-14 |
| Biomet, Inc. | 7 | 2017-10-05 |
| Osartis GmbH | 5 | 2021-05-18 |
| G21, S.R.L. | 5 | 2020-03-19 |
19 more applicants have LOD clearances. See the full list in Caduvo.
Most recent LOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254107 | Biomet France | Refobacin Bone Cement R (110034355) | 2026-04-15 | 117 |
| K250760 | Osteoremedies, LLC | SPECTRUM GV Bone Cement | 2025-04-02 | 20 |
| K241674 | Heraeus Medical GmbH | OSTEOPAL® V | 2024-12-05 | 177 |
| K231556 | Osteoremedies, LLC | SPECTRUM® GV Bone Cement | 2023-12-20 | 204 |
| K211163 | Tecres S.P.A. | Bone Cement Genta, Bone Cement HV, Bone Cement LV | 2023-01-09 | 630 |
Recalls for LOD devices
36 product recalls in 11 recall events; 8 initiated in the last five years and 12 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2020 | 1 |
| 2021 | 18 |
| 2022 | 2 |
| 2025 | 4 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code LOD?
LOD is the FDA product code for bone cement. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is LOD?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
How long does a 510(k) take for product code LOD?
Across 72 cleared submissions the average was 167 days from receipt to decision (median 126).
Which companies have the most LOD clearances?
Heraeus Medical GmbH (9); DePuy Orthopaedics, Inc. (9); Biomet, Inc. (7); Osartis GmbH (5); G21, S.R.L. (5).
Have LOD devices been recalled?
Yes: 36 product recalls across 11 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LOD
- Run a recall and safety report across every LOD manufacturer
- Watch product code LOD 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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