PBFClass II
Orthopaedic Surgical Planning And Instrument Guides
21 CFR 888.3030 / Orthopedic
PBF is the FDA product code for Orthopaedic Surgical Planning And Instrument Guides, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "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". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PBF
- Device name
- Orthopaedic Surgical Planning And Instrument Guides
- FDA 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.
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 0
Clearances, product code PBF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 8 |
| 2026 | 1 |
Applicants with the most clearances
Product code PBF| Applicant | Clearances |
|---|---|
| MedCAD | 4 |
| Newclip Technics | 4 |
| 3D Systems, Inc. | 3 |
| Bodycad Laboratories, Inc. | 3 |
| Materialise N.V. | 3 |
| Medacta International SA | 2 |
| 3D Lifeprints UK, Ltd. | 1 |
| 3D-Side | 1 |
| Additive Orthopaedics, LLC | 1 |
| Blue Belt Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.