FDA product code PBF: Orthopaedic Surgical Planning And Instrument Guides
PBF is the FDA product code for orthopaedic surgical planning and instrument guides. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 27 510(k) submissions under PBF, 20 in the last five years, from 15 different applicants. The average 510(k) review took 230 days (median 224); 202 days on average over the last three years.
Definition
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.
Classification
| Field | Value |
|---|---|
| Device name | Orthopaedic Surgical Planning And Instrument Guides |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for PBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 69 |
| 2019 | 1 | 224 |
| 2020 | 1 | 139 |
| 2021 | 2 | 166 |
| 2022 | 3 | 322 |
| 2023 | 5 | 302 |
| 2024 | 3 | 121 |
| 2025 | 8 | 217 |
| 2026 | 1 | 269 |
Compare with all 510(k) review times · Search every PBF clearance
Top PBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medcad | 4 | 2026-03-27 |
| Newclip Technics | 4 | 2025-10-01 |
| Bodycad Laboratories, Inc. | 3 | 2025-10-21 |
| Materialise NV | 3 | 2017-01-18 |
| 3D Systems, Inc. | 2 | 2025-12-05 |
10 more applicants have PBF clearances. See the full list in Caduvo.
Most recent PBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252064 | Medcad | MedCAD® AccuStride System | 2026-03-27 | 269 |
| K250711 | 3D Systems, Inc. | VSP Orthopedics System | 2025-12-05 | 270 |
| K242603 | Medacta International S.A. | MyPAO SA guides | 2025-11-19 | 446 |
| K251709 | Medcad | MedCAD® AccuStride System | 2025-11-04 | 154 |
| K250394 | Bodycad Laboratories, Inc. | Fine TTO | 2025-10-21 | 251 |
Recalls for PBF devices
openFDA lists no recalls for product code PBF.
Frequently asked questions
What is FDA product code PBF?
PBF is the FDA product code for orthopaedic surgical planning and instrument guides. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is PBF?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBF?
Across 27 cleared submissions the average was 230 days from receipt to decision (median 224).
Which companies have the most PBF clearances?
Medcad (4); Newclip Technics (4); Bodycad Laboratories, Inc. (3); Materialise NV (3); 3D Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PBF
- Run a recall and safety report across every PBF manufacturer
- Watch product code PBF 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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