Lupine
Catalogue number 210704, listed by DePuy Mitek, Inc., United States, under Fastener, Fixation, Biodegradable, Soft Tissue. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
25recalls on this code
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 | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K040827 |
| Record published | 2025-03-04 |
| Record revised | 2025-10-06 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 210704 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243790 | 2025-02-05 |
| K241010 | 2024-09-11 |
| K240441 | 2024-03-15 |
Recalls Naming This Product
17 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 | 295 units | 2015-08-05 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-11-04 | Class II | Employee error | Specific product codes and lots of the Mitek HEALIX ADVANCE” Knotless Anchors were manufactured with BIOCRYL” Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective | 299 | 2020-05-05 |
| 2019-11-04 | Class II | Employee error | Specific product codes and lots of the Mitek HEALIX ADVANCE” Knotless Anchors were manufactured with BIOCRYL” Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective | 599 | 2020-05-05 |
| 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 291 units | 2015-08-05 |
| 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 585 units | 2015-08-05 |
| 2011-10-31 | Not classified | Employee error | Incorrect suture configuration | 299 units | 2015-08-05 |
| 2006-02-17 | Not classified | Other | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. | 200 pieces | 2006-06-28 |
| 2006-02-17 | Not classified | Other | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. | 200 pieces | 2006-06-28 |
| 2005-10-27 | Not classified | Other | The device may contain one strand of suture instead of two strands | 19 boxes (5 pieces each) | 2006-05-02 |
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.