Biomet Kirschner Wires (K-Wires)
FDA 510(k) K241014 · Biomet, Inc.
510(k) numberK241014
Submission
- Device name
- Biomet Kirschner Wires (K-Wires)
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- April 12, 2024
- Decision date
- May 22, 2024
- 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
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| 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 |
| 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 |
| K231905 | Electro-Spec Steri-CapsHTY · Traditional | Electro-Spec, Inc. | 08/14/2023SE |
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| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
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Questions and answers
When was Biomet Kirschner Wires (K-Wires) cleared by the FDA?
Biomet Kirschner Wires (K-Wires) (K241014) received a 510(k) decision of Substantially Equivalent on May 22, 2024, 40 days after the submission was received.
What is the product code of K241014?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.