Oti Orthopedic Fastener System
FDA 510(k) K925301 · Osteo Technology, Inc.
510(k) numberK925301
Submission
- Device name
- Oti Orthopedic Fastener System
- Applicant
- Osteo Technology, Inc.
Timonium, MD, US - Received
- October 21, 1992
- Decision date
- March 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K926156 | Replica(Tm) Total Hip SystemLPH · Traditional | 03/09/1994SN |
| K922859 | Anatomical Type Knee SystemJWH · Traditional | 09/23/1993SE |
| K922869 | Total Condylat Type Knee SystemJWH · Traditional | 07/13/1993SE |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | 06/29/1993SE |
| K926213 | Modified Zickel Intramedullary Rod SystemHSB · Traditional | 06/17/1993SE |
| K922861 | Biometric Screw Fixation CupJDL · Traditional | 05/12/1993SE |
| K922870 | Three Spike CupGRF · Traditional | 04/08/1993SE |
| K922682 | Americana Hip ProthesisJDG · Traditional | 03/16/1993SE |
| K922871 | Unifit Femoral StemJDI · Traditional | 02/12/1993SE |
| K922868 | Thompson Type Hip ProthesisKWA · Traditional | 02/12/1993SE |
Questions and answers
When was Oti Orthopedic Fastener System cleared by the FDA?
Oti Orthopedic Fastener System (K925301) received a 510(k) decision of Substantially Equivalent on March 16, 1993, 146 days after the submission was received.
What is the product code of K925301?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.