Bioknotless Panacryl Ethibond
BIOKNOTLESS BR Anchor w/PANACRYL TCP/PLGA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided absorbable suture anchor loop, Size 2/0 green ETHIBOND polyester non-absorbable suture…
BIOKNOTLESS BR Anchor w/PANACRYL TCP/PLGA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided absorbable suture anchor loop, Size 2/0 green ETHIBOND polyester non-absorbable suture utility loop.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | GAS |
| Device type | Suture, Nonabsorbable, Synthetic, Polyester |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K040827 |
| Record published | 2015-09-01 |
| Record revised | 2025-10-06 (version 8) |
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 |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 212723 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atramat | Internacional Farmacéutica S.A DE C.V | 49 |
| TopLock | Fusion Orthopedics, LLC | 33 |
| RAM® COR-Suture® Quick Load® | LSI Solutions Inc. | 15 |
| A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 10 |
| Riverbond | Riverpoint Medical LLC | 7 |
| Polybond | Riverpoint Medical LLC | 6 |
| Fast-FIX | Smith & Nephew, Inc. | 3 |
| COR-Suture® Quick Load® | LSI Solutions Inc. | 2 |
| RD® Quick Load® | LSI Solutions Inc. | 2 |
| GII Ethibond | DePuy Mitek, Inc. | 2 |
| Rapidloc Ethibond | DePuy Mitek, Inc. | 2 |
| ALLthread Titanium | Biomet Orthopedics | 2 |
Showing 12 of 16. All products under Suture, Nonabsorbable, Synthetic, Polyester
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 |
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 |
|---|---|---|---|
| P880094 | 1989-09-22 | DACRON SURGICAL SUTURES | Alcon Laboratories, Inc. |
| P840041 | 1989-08-08 | NOVAFIL(TM) | Davis & Geck, Inc. |
| N83509 | 1987-02-20 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. |
| N17809 | 1986-12-03 | ETHIBOND* | Ethicon, Inc. |
| N80950 | 1985-03-22 | POLYVIOLENE SUTURE | Look, Inc. |
| N17804 | 1984-03-27 | ETHIBOND* | Ethicon, 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.