Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
FDA 510(k) K213982 · Pacific Instruments
510(k) numberK213982
Submission
- Device name
- Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
- Applicant
- Pacific Instruments
Honolulu, HI, US - Received
- December 20, 2021
- Decision date
- February 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
Questions and answers
When was Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires cleared by the FDA?
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires (K213982) received a 510(k) decision of Substantially Equivalent on February 17, 2022, 59 days after the submission was received.
What is the product code of K213982?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.