FDA product code NDN: Cement, Bone, Vertebroplasty
NDN is the FDA product code for cement, bone, vertebroplasty. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. FDA has cleared 108 510(k) submissions under NDN, 10 in the last five years, from 62 different applicants. The average 510(k) review took 154 days (median 122); 145 days on average over the last three years. FDA has posted 86 recalls for NDN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cement, Bone, Vertebroplasty |
| 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 NDN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 161 |
| 2018 | 3 | 141 |
| 2019 | 2 | 82 |
| 2020 | 4 | 159 |
| 2021 | 2 | 100 |
| 2022 | 2 | 72 |
| 2023 | 2 | 220 |
| 2024 | 3 | 96 |
| 2025 | 2 | 118 |
| 2026 | 1 | 222 |
Compare with all 510(k) review times · Search every NDN clearance
Top NDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrocare Corp. | 6 | 2011-02-16 |
| Tecres S.P.A. | 5 | 2022-04-18 |
| Stryker Corporation | 5 | 2020-10-20 |
| Teknimed, S.A. | 4 | 2011-01-03 |
| Dfine, Inc. | 4 | 2009-12-30 |
57 more applicants have NDN clearances. See the full list in Caduvo.
Most recent NDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251896 | Xelite Biomed , Ltd. | XeliteMed SuperM-Fix Spinal Bone Cement | 2026-01-28 | 222 |
| K250637 | Amber Implants | VCFix Spinal System | 2025-05-30 | 88 |
| K243537 | Xelite Biomed , Ltd. | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | 2025-04-11 | 147 |
| K241775 | Xelite Biomed , Ltd. | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | 2024-09-18 | 90 |
| K232842 | Ningbo Hicren Biotechnology Co., Ltd. | Balloon Inflation System | 2024-02-29 | 168 |
Recalls for NDN devices
86 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-12-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 73 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code NDN?
NDN is the FDA product code for cement, bone, vertebroplasty. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is NDN?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDN?
Across 108 cleared submissions the average was 154 days from receipt to decision (median 122).
Which companies have the most NDN clearances?
Arthrocare Corp. (6); Tecres S.P.A. (5); Stryker Corporation (5); Teknimed, S.A. (4); Dfine, Inc. (4).
Have NDN devices been recalled?
Yes: 86 product recalls across 10 recall events; the most recent began 2022-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NDN
- Run a recall and safety report across every NDN manufacturer
- Watch product code NDN 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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