Prefix Fixator
Prefix Fixator: 25 catalogue numbers listed by Orthofix SRL, Italy, under Pin, Fixation, Threaded. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
25catalogue numbers in this listing
2510(k) clearances naming this product code
23recalls 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 | Orthofix SRL, Italy |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K955848 |
| Record published | 2018-05-08 |
| Record revised | 2025-10-24 (version 9) |
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, manufacturing date, serial number |
| Sizes | Width 8 to 136 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Width 136 mm | In distribution |
| 1 | Width 132 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 133 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 135 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 9 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 10 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 134 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 8 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 11 mm | In distribution |
| 1 | In distribution |
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 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974186 | 1998-03-18 |
| K955848 | 1996-03-20 |
Recalls Naming This Product
23 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 |
|---|---|---|---|---|---|---|---|
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2018-09-27 | Class II | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | 2022-02-01 | |
| Orthofix SRL | 510(k) number | 2010-02-22 | Not classified | Nonconforming Material/Component | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. | 9 | 2010-05-05 |
| Orthofix SRL | 510(k) number | 2010-02-22 | Not classified | Nonconforming Material/Component | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. | 25 | 2010-05-05 |
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.