No-Profile Screws No-Profile Washer No-Profile Screws Washerloc Washers
FDA 510(k) K122437 · Biomet Sports Medicine
510(k) numberK122437
Submission
- Device name
- No-Profile Screws No-Profile Washer No-Profile Screws Washerloc Washers
- Applicant
- Biomet Sports Medicine
Warsaw, IN, US - Received
- August 10, 2012
- Decision date
- October 18, 2013
- 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 |
|---|---|---|
| K140908 | Juggerknot Mini Soft AnchorDZL · Traditional | 10/02/2014SE |
| K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…MBI · Traditional | 03/18/2013SE |
| K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorMBI · Traditional | 08/19/2011SE |
| K111564 | Maxfire Marxmen Meniscal Repair DeviceMBI · Special | 06/16/2011SE |
| K110039 | Biomet Sports Medicine Sternal Closure SystemJDQ · Traditional | 05/03/2011SE |
| K103145 | Hammerloc TM Tibial Fixation DeviceMBI · Traditional | 02/09/2011SE |
| K101063 | Sleeve with Ziploop Fixation DevicesMBI · Traditional | 06/23/2010SE |
| K083070 | Toggleloc SystemMBI · Traditional | 12/16/2008SE |
| K071816 | Harpoon Suture AnchorHWC · Traditional | 09/20/2007SE |
| K071704 | Sleeve and Button Soft Tissue DevicesMBI · Traditional | 09/17/2007SE |
Questions and answers
When was No-Profile Screws No-Profile Washer No-Profile Screws Washerloc Washers cleared by the FDA?
No-Profile Screws No-Profile Washer No-Profile Screws Washerloc Washers (K122437) received a 510(k) decision of Substantially Equivalent on October 18, 2013, 434 days after the submission was received.
What is the product code of K122437?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.