Orthofix External Fixation Screw (Pin) With Hydroxyapatite Coating
Xcaliber Osteotite Blunt Screw L 260/50 MM Thread D 6.0-5.6MM
9manufacturers in China registered for this device type
71catalogue 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 |
| Record published | 2015-09-01 |
| Record revised | 2026-05-07 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 4 to 6 mm; length 70 to 260 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Thread Diameter 6-5 mm | In distribution |
| 1 | Thread Length 30 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Diameter 6-5 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Diameter 6.0-5.6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 220 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Length 25 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Diameter 6-5 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Thread Diameter 3.5 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Thread Diameter 6-5 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Length 50 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | THREAD LENGTH 20 MM | 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
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 |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| 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 |
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.