Bioknotless Orthocord Ethibond
BIOKNOTLESS Plus Anchor w/ORTHOCORD PLA Absorbable Anchor, Size 2 (5 metric) ORTHOCORD Braided Composite suture anchor loop, Size 2/0 green ETHIBOND braided polyester suture utility loop.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K040827 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-11 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 26 °C; Handling environment temperature up to 80 °F; Handling environment temperature up to 26 °C; Storage environment temperature up to 80 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 212722 | In distribution | |
| 212726 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
Recalls Naming This Product
21 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 |
|---|---|---|---|---|---|---|---|
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 805 units | |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 540 units | |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 2372 units | |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 3328 units | |
| DePuy Mitek, Inc. | 510(k) number | 2023-04-13 | Class II | Use error | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter t | 1125 units | |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 41581 | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 1243 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 1757 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 32408 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 24146 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 2015-08-05 | |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 56468 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 2015-08-05 | |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 20476 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2012-01-27 | Not classified | Process control | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair | 12774 | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 298 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 299 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 291 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 585 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 295 units | 2015-08-05 |
| DePuy Mitek, Inc. | 510(k) number | 2008-04-29 | Not classified | Employee error | Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorr | 105 units | 2008-10-02 |
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.