The Bone Tie
FDA 510(k) K982719 · Surgicraft , Ltd.
510(k) numberK982719
Submission
- Device name
- The Bone Tie
- Applicant
- Surgicraft , Ltd.
Redditch, Worcs., GB - Received
- August 4, 1998
- Decision date
- September 25, 1998
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K091207 | Surgicraft Lockdown Acromioclavicular (Ac) DeviceHTN · Traditional | 02/15/2011SE |
| K072370 | Surgicraft Surgical Mesh SystemFTL · Traditional | 07/24/2008SE |
| K080447 | Surgicraft Screw Fixation SystemMBI · Traditional | 06/13/2008SE |
| K073109 | Stalif TT Intervertebral Body Fusion SystemOVD · Abbreviated | 06/04/2008SE |
| K072415 | Stalif (TM) COVE · Abbreviated | 01/25/2008SE |
| K051027 | Stalif TTMQP · Traditional | 06/29/2005SE |
| K041617 | Stalif TTMQP · Traditional | 09/08/2004SE |
| K991662 | Titanium Hartshill SystemKWP · Traditional | 11/08/1999SE |
| K965221 | Ransford Cervical Fixation SystemKWP · Traditional | 08/07/1997SE |
Questions and answers
When was The Bone Tie cleared by the FDA?
The Bone Tie (K982719) received a 510(k) decision of Substantially Equivalent on September 25, 1998, 52 days after the submission was received.
What is the product code of K982719?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.