Versalok Orthocord
VERSALOK PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)
31manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K100532 |
| Record published | 2015-09-01 |
| Record revised | 2025-10-06 (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 26 °C; Handling environment temperature up to 26 °C; Handling environment temperature up to 80 °F; Storage environment temperature up to 80 °F |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 210818 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120449 | 2012-05-11 |
| K060664 | 2006-06-06 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|
| 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 |
Recalls
21 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 |
|---|---|---|---|---|---|
| 2017-05-12 | Class II | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | 173 units | 2018-10-03 |
| 2017-05-12 | Class II | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | 184 units | 2018-10-03 |
| 2017-05-12 | Class II | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | 184 units | 2018-10-03 |
| 2017-05-12 | Class II | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | 115 units | 2018-10-03 |
| 2017-05-12 | Class II | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw | 153 units | 2018-10-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 4,321 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 94 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 4,151 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 2560 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 66 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 372 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 1315 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 232 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 400 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 7 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 0 | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 314 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 0 | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 7 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 25,393 units | 2015-06-03 |
| 2012-09-06 | Class II | Device Design | Fracture of SPIRALOK Anchors post op, requiring patient revision | 39,362 units | 2015-06-03 |
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.