INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
FDA 510(k) K232886 · Healthium Medtech Limited
510(k) numberK232886
Submission
- Device name
- INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- Applicant
- Healthium Medtech Limited
Bangalore, IN - Received
- September 18, 2023
- Decision date
- November 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK AnchorMBI · Traditional | 01/04/2024SE |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair ImplantMBI · Traditional | 12/28/2023SE |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…MBI · Traditional | 08/04/2023SE |
| K223889 | Stativ® Knotted UHMWPE Suture AnchorMBI · Traditional | 03/22/2023SE |
Questions and answers
When was INFILOOP® Fixed Loop UHMWPE Suture Titanium Button cleared by the FDA?
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (K232886) received a 510(k) decision of Substantially Equivalent on November 8, 2023, 51 days after the submission was received.
What is the product code of K232886?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.