Orthomet Pin System
FDA 510(k) K874913 · Orthomet, Inc.
510(k) numberK874913
Submission
- Device name
- Orthomet Pin System
- Applicant
- Orthomet, Inc.
Minneapolis, MN, US - Received
- December 3, 1987
- Decision date
- January 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K936310 | Orthomet HMC Femoral Stem ComponentLPH · Traditional | 06/07/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | 05/30/1995SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | 04/26/1995SE |
| K944752 | Orthomet Resurfacing Femoral ComponentKXA · Traditional | 12/28/1994SE |
| K930771 | Perfecta Total Hip System Coated Cocr Femoral StemJDI · Traditional | 11/30/1994SN |
| K926334 | Axiom Total Knee Syst/Acl Retain Tibial Tray/InserJWH · Traditional | 10/18/1994SN |
| K932677 | Axiom Total Knee SystemJWH · Traditional | 10/14/1994SE |
| K931678 | Orthomet LHMC Femoral StemHMC · Traditional | 10/14/1994SE |
| K931333 | Orthomet Acetabular Cup SystemLPH · Traditional | 10/14/1994SE |
| K925536 | Hybrid Femoral Stem, Perfecta Total Hip SystemKWY · Traditional | 01/07/1994SN |
Questions and answers
When was Orthomet Pin System cleared by the FDA?
Orthomet Pin System (K874913) received a 510(k) decision of Substantially Equivalent on January 7, 1988, 35 days after the submission was received.
What is the product code of K874913?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.