Biofix Absorbable Self-Reinforced Poly-L-Lactide
FDA 510(k) K925098 · Bioscience, Inc.
510(k) numberK925098
Submission
- Device name
- Biofix Absorbable Self-Reinforced Poly-L-Lactide
- Applicant
- Bioscience, Inc.
Washington, DC, US - Received
- October 8, 1992
- Decision date
- July 19, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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
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 |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K955768 | Biofix Biodegradable Meniscus Arrow SystemMAI · Traditional | 03/04/1996SN |
| K955003 | Biofix Biodegradable Self-Reinforced Poly-L-Lactide (Sr-Plla) Mini-TackMAI · Traditional | 01/31/1996SE |
| K952471 | Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation RodMAI · Traditional | 08/07/1995SE |
Questions and answers
When was Biofix Absorbable Self-Reinforced Poly-L-Lactide cleared by the FDA?
Biofix Absorbable Self-Reinforced Poly-L-Lactide (K925098) received a 510(k) decision of Substantially Equivalent for Some Indications on July 19, 1994, 649 days after the submission was received.
What is the product code of K925098?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.