Lupine Orthocord
LUPINE Loop Dual Suture (DS) Anchor PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composite sutures, Violet and Blue 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD…
LUPINE Loop Dual Suture (DS) Anchor PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composite sutures, Violet and Blue 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K040827 |
| Record published | 2015-09-01 |
| Record revised | 2021-01-28 (version 7) |
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 80 °F; Storage environment temperature up to 26 °C; Handling environment temperature up to 80 °F; Handling environment temperature up to 26 °C |
| Distribution end date | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 222981 | Withdrawn | |
| 222980 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, Inc. |
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.