FDA product code PLF: Bone Wedge
PLF is the FDA product code for bone wedge. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 18 510(k) submissions under PLF, 9 in the last five years, from 12 different applicants. The average 510(k) review took 121 days (median 90); 130 days on average over the last three years. FDA has posted 9 recalls for PLF devices, 2 initiated in the last five years.
Definition
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Classification
| Field | Value |
|---|---|
| Device name | Bone Wedge |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PLF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 124 |
| 2019 | 2 | 145 |
| 2020 | 2 | 53 |
| 2021 | 1 | 395 |
| 2022 | 2 | 37 |
| 2023 | 1 | 90 |
| 2024 | 3 | 118 |
| 2025 | 2 | 97 |
| 2026 | 1 | 175 |
Compare with all 510(k) review times · Search every PLF clearance
Top PLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nvision Biomedical Technologies, Inc. | 5 | 2022-12-01 |
| Nvision Biomedical Technologies | 2 | 2024-11-08 |
| Tyber Medical, LLC | 2 | 2017-05-16 |
| MiRus, LLC | 1 | 2026-02-19 |
| Sinaptic Surgical | 1 | 2025-10-17 |
7 more applicants have PLF clearances. See the full list in Caduvo.
Most recent PLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252733 | MiRus, LLC | ATLAS Expandable Osteotomy Wedge System | 2026-02-19 | 175 |
| K252254 | Sinaptic Surgical | Osteotomy Wedge System | 2025-10-17 | 88 |
| K251791 | Auxano Medical, LLC | Auxano® Wedge Fixation System | 2025-09-25 | 106 |
| K240461 | Ames Medical Prosthetic Solutions, S.A.U. | OsteoSinter® EVANS and COTTON wedges and related accessories | 2024-12-06 | 294 |
| K243231 | Nvision Biomedical Technologies | Trigon PEEK HA Wedges | 2024-11-08 | 30 |
Recalls for PLF devices
9 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-07-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code PLF?
PLF is the FDA product code for bone wedge. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is PLF?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLF?
Across 18 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most PLF clearances?
Nvision Biomedical Technologies, Inc. (5); Nvision Biomedical Technologies (2); Tyber Medical, LLC (2); MiRus, LLC (1); Sinaptic Surgical (1).
Have PLF devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2026-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code PLF
- Run a recall and safety report across every PLF manufacturer
- Watch product code PLF 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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