Memometal Intra-Medullary Bone Fastener
FDA 510(k) K112197 · Memometal Technologies
510(k) numberK112197
Submission
- Device name
- Memometal Intra-Medullary Bone Fastener
- Applicant
- Memometal Technologies
Bruz, FR - Received
- August 1, 2011
- Decision date
- November 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
|---|---|---|
| K101930 | Memometal Navis Bone Plating SystemHRS · Traditional | 03/15/2011SE |
| K102072 | Memometal Implants (K-Snap & Ti-Fuse)HTY · Traditional | 11/03/2010SE |
| K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115HWC · Traditional | 05/19/2010SE |
| K083447 | Memometal Anchorage Bone Plate System, Models Plss/Plsl, PLP10/PLP20/PLP30/PLP40/PLP50HRS · Traditional | 02/06/2009SE |
| K071941 | Memometal Bone AnchorsHWC · Traditional | 12/04/2007SE |
| K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseHTY · Traditional | 07/26/2007SE |
| K070039 | Memometal Fixos ScrewsHWC · Traditional | 03/21/2007SE |
| K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10JDR · Traditional | 03/19/2007SE |
| K070031 | Memometal Memory StaplesJDR · Traditional | 03/19/2007SE |
Questions and answers
When was Memometal Intra-Medullary Bone Fastener cleared by the FDA?
Memometal Intra-Medullary Bone Fastener (K112197) received a 510(k) decision of Substantially Equivalent on November 17, 2011, 108 days after the submission was received.
What is the product code of K112197?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.