XtraFix® Large External Fixation System
19 catalogue numbers from 00-5204-050-55, listed by Zimmer, Inc., United States, under Pin, Fixation, Threaded. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
20recalls 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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113383 |
| Record published | 2016-07-13 |
| Record revised | 2026-05-15 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 100 to 250 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5204-050-55 | Ø5 mm 160 mm Length 55 mm Thread Length | In distribution |
| 00-5205-050-30 | Length 120 mm | In distribution |
| 00-5204-050-85 | Ø5 mm 250 mm Length 85 mm Thread Length | In distribution |
| 00-5205-040-20 | 4 mm Diameter, 20 mm Thread Length | In distribution |
| 00-5204-050-65 | Ø5 mm 200 mm Length 65 mm Thread Length | In distribution |
| 00-5204-030-25 | Ø3 mm 100 mm Length 25 mm Thread Length | In distribution |
| 00-5205-050-45 | Length 200 mm | In distribution |
| 00-5204-050-35 | Ø5 mm 160 mm Length 35 mm Thread Length | In distribution |
| 00-5204-050-45 | Ø5 mm 200 mm Length 45 mm Thread Length | In distribution |
| 00-5205-050-65 | Length 200 mm | In distribution |
| 00-5204-040-20 | Ø4 mm 100 mm Length 20 mm Thread Length | In distribution |
| 00-5205-050-35 | 5 mm Diameter, 35 mm Thread Length | In distribution |
| 00-5204-040-35 | Ø4 mm 100 mm Length 35 mm Thread Length | In distribution |
| 00-5204-060-85 | 6 mm Diameter, 85 mm Thread Length | In distribution |
| 00-5204-060-55 | Ø6 mm 200 mm Length 55 mm Thread Length | In distribution |
| 00-5204-090-28 | Ø5 mm Shaft 275 mm Length Ø6 mm Thread | In distribution |
| 00-5204-030-15 | Ø3 mm 100 mm Length 15 mm Thread Length | In distribution |
| 00-5205-030-15 | 3 mm Diameter, 15 mm Thread Length | In distribution |
| 00-5205-050-55 | Length 160 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 |
|---|---|
| K955780 | 1996-02-09 |
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 | Closed |
|---|---|---|---|---|
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
| 2003-10-15 | Not classified | Other | The pin may fail because the metal used to make the pin does not meet the firm’s hardness specification. | 2004-05-20 |
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.