FDA product code PML: Bone Cement, Posterior Screw Augmentation
PML is the FDA product code for bone cement, posterior screw augmentation. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. FDA has cleared 19 510(k) submissions under PML, 8 in the last five years, from 16 different applicants. The average 510(k) review took 147 days (median 134); 96 days on average over the last three years. FDA has posted 2 recalls for PML devices, 2 initiated in the last five years.
Definition
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Classification
| Field | Value |
|---|---|
| Device name | Bone Cement, Posterior Screw Augmentation |
| 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 PML
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 117 |
| 2018 | 2 | 258 |
| 2019 | 2 | 167 |
| 2020 | 3 | 164 |
| 2021 | 1 | 80 |
| 2022 | 2 | 101 |
| 2023 | 3 | 111 |
| 2024 | 1 | 57 |
| 2026 | 2 | 136 |
Compare with all 510(k) review times · Search every PML clearance
Top PML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icotec AG | 2 | 2023-01-09 |
| Neo Medical SA | 2 | 2022-08-26 |
| Medtronic | 2 | 2020-08-19 |
| Spine Wave, Inc. | 1 | 2026-06-15 |
| Astura Medical | 1 | 2026-01-22 |
11 more applicants have PML clearances. See the full list in Caduvo.
Most recent PML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260286 | Spine Wave, Inc. | Dynamo Spinal Cement; Salvo® Spine System | 2026-06-15 | 137 |
| K252885 | Astura Medical | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | 2026-01-22 | 134 |
| K241034 | Medacta International S.A. | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | 2024-06-12 | 57 |
| K231809 | Ulrich Medical USA | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | 2023-10-20 | 122 |
| K230774 | Spineart | PERLA® TL System; TEKTONA® HV US Bone Cement | 2023-06-23 | 94 |
Recalls for PML devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-11-28.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code PML?
PML is the FDA product code for bone cement, posterior screw augmentation. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is PML?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
How long does a 510(k) take for product code PML?
Across 19 cleared submissions the average was 147 days from receipt to decision (median 134).
Which companies have the most PML clearances?
Icotec AG (2); Neo Medical SA (2); Medtronic (2); Spine Wave, Inc. (1); Astura Medical (1).
Have PML devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-11-28.
Next steps
- Run an FDA pathway report with predicate devices for product code PML
- Run a recall and safety report across every PML manufacturer
- Watch product code PML 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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