Juggerknot®
77 catalogue numbers from 912036, listed by Biomet Orthopedics, United States, under Fastener, Fixation, Nondegradable, Soft Tissue. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K110145 |
| Record published | 2017-07-28 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 912036 | 1.4 MM | In distribution | |
| 912038C | In distribution | ||
| 912072 | 1.4 mm | In distribution | |
| 916037 | In distribution | ||
| 110005306 | 2.9 mm | In distribution | |
| 110025773 | 1.8 MM | In distribution | |
| 110025796 | In distribution | ||
| 110025822 | 1.4 MM | In distribution | |
| 912038P | In distribution | ||
| 912035C | In distribution | ||
| 110025771 | 2.1 MM | In distribution | |
| 916020 | Long | In distribution | |
| 912037R | 1.5 mm Large | In distribution | |
| 912037 | 1.5 mm | In distribution | |
| 110025772 | 1.8 MM | In distribution | |
| 110016951 | 2.9 MM | In distribution | |
| 912041 | 1.5 mm | In distribution | |
| 110025863 | 2.1 MM | In distribution | |
| 912071 | 1.4 MM | In distribution | |
| 912041C | 1.5 mm | In distribution | |
| 912064 | 2.9 mm | In distribution | |
| 912071 | 1.4 mm Short | In distribution | |
| 912091 | 2.9 MM | In distribution | |
| SSI004384 | In distribution | ||
| 110025877 | 1.5 MM | In distribution | |
| 912059 | 2.9 MM | In distribution | |
| SSI000809 | In distribution | ||
| 110025793 | In distribution | ||
| 110002759 | Long | In distribution | |
| 912077 | 1.0MM MINI | In distribution | |
| 110025823 | 1.4 MM | In distribution | |
| 110025876 | 1.4 MM | In distribution | |
| SSI000072 | In distribution | ||
| 912071 | In distribution | ||
| 912046 | 1.5 mm | In distribution | |
| X01016664 | 2.9mm Diameter | In distribution | |
| 912136 | 1.4 mm | In distribution | |
| 912057 | 2.9 mm | In distribution | |
| 110025769 | 2.1 MM | In distribution | |
| 912040C | 1.4 mm | In distribution | |
| 110025821 | 1.4 MM | In distribution | |
| 110016951 | 2.9MM | In distribution | |
| 912035 | 1.4 mm/ 1.5 mm | In distribution | |
| 912073 | 1.4MM | In distribution | |
| 912092G | 2.9 mm | In distribution | |
| 916039 | Long | In distribution | |
| 110025770 | 2.1 MM | In distribution | |
| 912091 | 2.9 mm | In distribution | |
| 110025794 | In distribution | ||
| 912141C | 1.5 mm | In distribution | |
| 912039 | In distribution | ||
| 916038 | Long | In distribution | |
| 912093G | 2.9 mm | In distribution | |
| 916034 | In distribution | ||
| 912036 | 1.4 MM | In distribution | |
| 912077 | 1.0 mm | In distribution | |
| 110016992 | In distribution | ||
| 916040 | Long | In distribution | |
| 912140C | 1.4 mm | In distribution | |
| 916036 | In distribution | ||
| 916035 | Long | In distribution | |
| 110025798 | In distribution | ||
| 110025800 | In distribution | ||
| 912090G | 2.9 mm | In distribution | |
| 110025797 | In distribution | ||
| 912040 | 1.4 mm | In distribution | |
| 110025820 | 1.4 MM | In distribution | |
| 912038 | In distribution | ||
| 110025774 | 1.8 MM | In distribution | |
| 912045 | 1.4 mm | In distribution | |
| 912073 | 1.4MM | In distribution | |
| 110005323 | 5 | In distribution | |
| 912039C | In distribution | ||
| 110025866 | 1.8 MM | In distribution | |
| 916039 | In distribution | ||
| 912040P | 1.4 mm | In distribution | |
| SSI000810 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2025-09-09 | Class II | Under Investigation by firm | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. | 40 | |
| Biomet, Inc. | 510(k) number | 2018-08-03 | Class II | Device Design | Expiration date incorrectly listed on the label | 217 units | 2020-04-10 |
| Biomet, Inc. | 510(k) number | 2016-04-01 | Class II | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it ma | 2017-05-23 | |
| Biomet, Inc. | 510(k) number | 2011-07-21 | Not classified | Package design/selection | The device packaging was punctured by the device, resulting in loss of implant sterility. | 4925 | 2013-04-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.