Orthofix Modulsystem
Selfdrilling Xcaliber Cylindrical Screw Shaft D.6MM Thread 6MM 180/60 QC Sterile
9manufacturers in China registered for this device type
583catalogue 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 | 2018-04-24 |
| Record revised | 2026-05-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 3 to 400 mm; outer diameter 2 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | Outer Diameter 2 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 220 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 25 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 35 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 3 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | Length 6 mm | In distribution |
| 1 | Length 3 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Thread Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 4 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Thread Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 260 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | THREAD LENGTH 25 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread 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 | Length 100 mm | In distribution |
| 1 | In distribution | |
| 1 | Thread Diameter 6-5 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 100 mm | In distribution |
| 1 | Length 5 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | THREAD DIAMETER 3 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Thread Length 50 mm | In distribution |
| 1 | Length 120 mm | In distribution |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | THREAD DIAMETER 4 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 200 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | In distribution | |
| 1 | Thread Diameter 3.5 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 260 mm | In distribution |
| 1 | Length 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 6-5 MM | In distribution |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Thread Length 50 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 | In distribution | |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 4 MM | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 260 mm | 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 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 120 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 110 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 150 mm | In distribution |
| 1 | In distribution | |
| 1 | THREAD DIAMETER 5 MM | In distribution |
| 1 | Length 100 mm | In distribution |
| 1 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| gSource | Gsource, LLC. | 74 |
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
27 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthofix US LLC | UDI-DI | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 48 units | |
| Orthofix US LLC | UDI-DI | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 19 units | |
| Orthofix US LLC | UDI-DI | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 32 units | |
| Orthofix US LLC | UDI-DI | 2026-06-10 | Class II | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | 62 units | |
| 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.