Other External Fixation
Kranendonk Skeletal Traction PIN Trocar PT 7.64 X0
9manufacturers in China registered for this device type
78catalogue numbers in this listing
8510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K120871 |
| Record published | 2015-08-25 |
| Record revised | 2023-09-07 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pkg of 2, box of 3, box of 5, box of 2 |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71050031 | In distribution | |
| 71033007 | In distribution | |
| 71934747 | In distribution | |
| 71929621 | In distribution | |
| 71050002 | In distribution | |
| 103451 | In distribution | |
| 71934748 | In distribution | |
| 71932961 | In distribution | |
| 71932951 | In distribution | |
| 71932953 | In distribution | |
| 71932949 | In distribution | |
| 71050009 | In distribution | |
| 71012020 | In distribution | |
| 71033008 | In distribution | |
| 71061001 | In distribution | |
| 103453 | In distribution | |
| 124841 | In distribution | |
| 71934746 | In distribution | |
| 110062 | In distribution | |
| 71932452 | In distribution | |
| 71012010 | In distribution | |
| 71930696 | In distribution | |
| 71932962 | In distribution | |
| 71022002 | In distribution | |
| 71022003 | In distribution | |
| 71050032 | In distribution | |
| 71050035 | In distribution | |
| 71932950 | In distribution | |
| 71050107 | In distribution | |
| 71033002 | In distribution | |
| 71929495 | In distribution | |
| 71040004 | In distribution | |
| 103406 | In distribution | |
| 71932948 | In distribution | |
| 71055025 | In distribution | |
| 103405 | In distribution | |
| 71053031 | In distribution | |
| 71033004 | In distribution | |
| 71033003 | In distribution | |
| 71061002 | In distribution | |
| 71022001 | In distribution | |
| 71061005 | In distribution | |
| 124839 | In distribution | |
| 71012015 | In distribution | |
| 124840 | In distribution | |
| 71932947 | In distribution | |
| 71061011 | In distribution | |
| 71053033 | In distribution | |
| 71061012 | In distribution | |
| 71061003 | In distribution | |
| 128177 | In distribution | |
| 71050006 | In distribution | |
| 71050008 | In distribution | |
| 103452 | In distribution | |
| 103455 | In distribution | |
| 71932963 | In distribution | |
| 71061016 | In distribution | |
| 71051012 | In distribution | |
| 71932945 | In distribution | |
| 71932946 | In distribution | |
| 71932952 | In distribution | |
| 71934745 | In distribution | |
| 103404 | In distribution | |
| 71061013 | In distribution | |
| 71061010 | In distribution | |
| 71033005 | In distribution | |
| 76522100 | Withdrawn | |
| 71929494 | Withdrawn | |
| 76522115 | Withdrawn | |
| 71925829 | Withdrawn | |
| 76522106 | Withdrawn | |
| 71927392 | Withdrawn | |
| 71053032 | Withdrawn | |
| 76522114 | Withdrawn | |
| 76522101 | Withdrawn | |
| 76522105 | Withdrawn | |
| 71927174 | Withdrawn | |
| 71053038 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| gSource | Gsource, LLC. | 74 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223112 | 2022-12-08 |
| K213874 | 2022-02-11 |
| K210784 | 2021-04-02 |
| K120871 | 2012-06-07 |
| K033289 | 2004-01-13 |
| K023921 | 2003-02-05 |
| K023134 | 2002-10-09 |
| K994143 | 2000-02-18 |
Recalls Naming This Product
46 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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 376 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 2362 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 2551 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1236 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 404 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 205 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1871 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 3776 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 7482 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 4655 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1439 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 179 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1977 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 541 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 634 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 244 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 308 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 635 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 2397 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 3057 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1416 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 208 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 124 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 474 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 735 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 552 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 452 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 176 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 147 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 51 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 27 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 42 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 91 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 328 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 813 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 933 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 503 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 513 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 41 units | 2015-09-22 |
| Smith & Nephew, Inc. | 510(k) number | 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 5 units | 2015-09-22 |
Showing 40 of 46.
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 10 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 15 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 5222 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 131 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 1547 units | 2015-09-22 |
| 2012-04-13 | Not classified | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. | 273 units | 2015-09-22 |
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.