GAP Endo-EXO Medullary System
Lag Screw & Nut Ø5.5mm X 100mm / A/F 6.0mm
17manufacturers in China registered for this device type
233catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Orthopediatrics Canada ULC, Canada |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| Record published | 2024-06-07 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: keep at room temperature |
| Sizes | Outer diameter 2.5 to 8 mm; length 20 to 320 mm; height 1.5 to 10 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAP-2N64-28 | Length 280 mm | In distribution |
| GAP-CS3-60/GAP-WAS100 | Length 60 mm | In distribution |
| GAP-CS2-55 | Length 55 mm | In distribution |
| GAP-2N48-28 | Outer Diameter 4.8 mm | In distribution |
| GAP-LG055/GAP-SSN55 | Length 55 mm | In distribution |
| GAP-CS2-24 | Length 24 mm | In distribution |
| GAP-CS2-65 | Outer Diameter 2.5 mm | In distribution |
| GAP-N56-32 | Outer Diameter 5.6 mm | In distribution |
| GAP-CS2-80/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-PLC120 | In distribution | |
| GAP-CS4-38 | Length 38 mm | In distribution |
| GAP-CS3-28/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-CS4-32/GAP-WAS100 | Length 32 mm | In distribution |
| GAP-N56-20 | Outer Diameter 5.6 mm | In distribution |
| GAP-CS2-38/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-2N48-18 | Length 180 mm | In distribution |
| GAP-CS2-20 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS3-55 | Outer Diameter 3 mm | In distribution |
| GAP-CS4-22 | Outer Diameter 4 mm | In distribution |
| GAP-CS3-32/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-2N48-32 | Outer Diameter 4.8 mm | In distribution |
| GAP-N72-24 | Length 240 mm | In distribution |
| GAP-LG080/GAP-SSN55 | Length 80 mm | In distribution |
| GAP-CS3-36/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-CS4-34 | Outer Diameter 4 mm | In distribution |
| GAP-N48-22 | Length 220 mm | In distribution |
| GAP-CS4-38/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS4-30 | Length 30 mm | In distribution |
| GAP-2N64-32 | Length 320 mm | In distribution |
| GAP-CS2-65/GAP-WAS100 | Length 65 mm | In distribution |
| GAP-LG110/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-2N56-16 | Outer Diameter 5.6 mm | In distribution |
| GAP-LG090/GAP-SSN55 | Length 90 mm | In distribution |
| GAP-CS4-75 | Length 75 mm | In distribution |
| GAP-N64-18 | Outer Diameter 6.4 mm | In distribution |
| GAP-N48-28 | Length 280 mm | In distribution |
| GAP-2N48-22 | Length 220 mm | In distribution |
| GAP-2N56-30 | Outer Diameter 5.6 mm | In distribution |
| GAP-LG050 | Length 50 mm | In distribution |
| GAP-CS2-45 | Length 45 mm | In distribution |
| GAP-LG065 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS4-36 | Length 36 mm | In distribution |
| GAP-CS2-45/GAP-WAS100 | Length 45 mm | In distribution |
| GAP-2N72-20 | Outer Diameter 7.2 mm | In distribution |
| GAP-2N72-18 | Outer Diameter 7.2 mm | In distribution |
| GAP-N72-20 | Length 200 mm | In distribution |
| GAP-2N64-18 | Length 180 mm | In distribution |
| GAP-CS3-45/GAP-WAS100 | Length 45 mm | In distribution |
| GAP-CS4-50 | Outer Diameter 4 mm | In distribution |
| GAP-N64-24 | Length 240 mm | In distribution |
| GAP-LG060/GAP-SSN55 | Length 60 mm | In distribution |
| GAP-PLC130 | In distribution | |
| GAP-N56-16 | Outer Diameter 5.6 mm | In distribution |
| GAP-CS2-40 | Outer Diameter 2.5 mm | In distribution |
| GAP-N64-22 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS3-20/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-N56-24 | Length 240 mm | In distribution |
| GAP-CS4-70/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-N64-28 | Length 280 mm | In distribution |
| GAP-N72-28 | Length 280 mm | In distribution |
| GAP-CS2-26 | Outer Diameter 2.5 mm | In distribution |
| GAP-2N48-16 | Outer Diameter 4.8 mm | In distribution |
| GAP-CP050 | Height 5 mm | In distribution |
| GAP-CS4-20 | Length 20 mm | In distribution |
| GAP-CS2-32/GAP-WAS100 | Length 32 mm | In distribution |
| GAP-CS3-30 | Length 30 mm | In distribution |
| GAP-CS4-26 | Length 26 mm | In distribution |
| GAP-LG085 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS4-55/GAP-WAS100 | Length 55 mm | In distribution |
| GAP-CS2-70/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-N72-30 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS3-80 | Length 80 mm | In distribution |
| GAP-CS3-75/GAP-WAS100 | Length 75 mm | In distribution |
| GAP-IMF200 | In distribution | |
| GAP-N56-30 | Length 300 mm | In distribution |
| GAP-N64-30 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS2-75 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS3-20 | Length 20 mm | In distribution |
| GAP-CS2-32 | Length 32 mm | In distribution |
| GAP-CS4-36/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-N56-22 | Length 220 mm | In distribution |
| GAP-N64-26 | Length 260 mm | In distribution |
| GAP-CS4-40 | Length 40 mm | In distribution |
| GAP-CS2-28 | Length 28 mm | In distribution |
| GAP-CS2-34 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS4-22/GAP-WAS100 | Length 22 mm | In distribution |
| GAP-CS2-20/GAP-WAS100 | Length 20 mm | In distribution |
| GAP-2N56-20 | Outer Diameter 5.6 mm | In distribution |
| GAP-CS2-22 | Length 22 mm | In distribution |
| GAP-CP100 | Height 10 mm | In distribution |
| GAP-LG080 | Length 80 mm | In distribution |
| GAP-CS4-65 | Length 65 mm | In distribution |
| GAP-N56-26 | Outer Diameter 5.6 mm | In distribution |
| GAP-CS2-30 | Outer Diameter 2.5 mm | In distribution |
| GAP-2N72-16 | Outer Diameter 7.2 mm | In distribution |
| GAP-LG085/GAP-SSN55 | Length 85 mm | In distribution |
| GAP-CS2-40/GAP-WAS100 | Length 40 mm | In distribution |
| GAP-CS3-34 | Length 34 mm | In distribution |
| GAP-N48-20 | Length 200 mm | In distribution |
| GAP-LG100 | Outer Diameter 5.5 mm | In distribution |
| GAP-IMF250 | In distribution | |
| GAP-2N72-30 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS2-80 | Length 80 mm | In distribution |
| GAP-CS3-34/GAP-WAS100 | Length 34 mm | In distribution |
| GAP-PLS100 | In distribution | |
| GAP-LG060 | Length 60 mm | In distribution |
| GAP-CS2-22/GAP-WAS100 | Length 22 mm | In distribution |
| GAP-LG075 | Length 75 mm | In distribution |
| GAP-N80-28 | Outer Diameter 8 mm | In distribution |
| GAP-CS4-70 | Length 70 mm | In distribution |
| GAP-LG095/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS4-26/GAP-WAS100 | Length 26 mm | In distribution |
| GAP-CS3-30/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-SSN55 | Outer Diameter 6 mm | In distribution |
| GAP-CS2-30/GAP-WAS100 | Length 30 mm | In distribution |
| GAP-CS3-80/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-CS4-28/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS3-38/GAP-WAS100 | Length 38 mm | In distribution |
| GAP-LG105 | Outer Diameter 5.5 mm | In distribution |
| GAP-MS34 | Length 34 mm | In distribution |
| GAP-CS2-28/GAP-WAS100 | Length 28 mm | In distribution |
| GAP-CS4-24 | Length 24 mm | In distribution |
| GAP-CS3-28 | Outer Diameter 3 mm | In distribution |
| GAP-CS3-24/GAP-WAS100 | Length 24 mm | In distribution |
| GAP-N56-28 | Length 280 mm | In distribution |
| GAP-CS4-40/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS2-36 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS2-34/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-WAS100 | In distribution | |
| GAP-2N56-18 | Outer Diameter 5.6 mm | In distribution |
| GAP-2N72-22 | Length 220 mm | In distribution |
| GAP-CS4-55 | Length 55 mm | In distribution |
| GAP-LG090 | Outer Diameter 5.5 mm | In distribution |
| GAP-LG110 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS2-60/GAP-WAS100 | Length 60 mm | In distribution |
| GAP-N80-32 | Outer Diameter 8 mm | In distribution |
| GAP-CS2-75/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-2N80-28 | Outer Diameter 8.0 mm | In distribution |
| GAP-CS2-38 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS2-50/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-MS24 | Length 24 mm | In distribution |
| GAP-CS4-50/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-N48-16 | Outer Diameter 4.8 mm | In distribution |
| GAP-CS4-80 | Outer Diameter 4 mm | In distribution |
| GAP-CS3-22 | Length 22 mm | In distribution |
| GAP-2N64-24 | Length 240 mm | In distribution |
| GAP-LG050/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS4-24/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS2-50 | Length 50 mm | In distribution |
| GAP-LG055 | Length 55 mm | In distribution |
| GAP-CS4-34/GAP-WAS100 | Length 34 mm | In distribution |
| GAP-2N48-20 | Outer Diameter 4.8 mm | In distribution |
| GAP-N48-18 | Length 180 mm | In distribution |
| GAP-CS4-28 | Length 28 mm | In distribution |
| GAP-2N64-26 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS3-45 | Outer Diameter 3 mm | In distribution |
| GAP-2N56-28 | Outer Diameter 5.6 mm | In distribution |
| GAP-2N72-26 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS4-80/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS3-32 | Length 32 mm | In distribution |
| GAP-CS3-40/GAP-WAS100 | Length 40 mm | In distribution |
| GAP-CS3-55/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-2N48-24 | Outer Diameter 4.8 mm | In distribution |
| GAP-CS3-50 | Outer Diameter 3 mm | In distribution |
| GAP-CS4-30/GAP-WAS100 | Length 30 mm | In distribution |
| GAP-CS3-60 | Length 60 mm | In distribution |
| GAP-2N80-32 | Outer Diameter 8.0 mm | In distribution |
| GAP-N72-22 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS3-38 | Length 38 mm | In distribution |
| GAP-PLL100 | In distribution | |
| GAP-LG075/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-N48-26 | Outer Diameter 4.8 mm | In distribution |
| GAP-CS3-24 | Outer Diameter 3 mm | In distribution |
| GAP-LG095 | Length 95 mm | In distribution |
| GAP-CS4-65/GAP-WAS100 | Length 65 mm | In distribution |
| GAP-CS3-26/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-N56-18 | Length 180 mm | In distribution |
| GAP-2N72-24 | Length 240 mm | In distribution |
| GAP-N72-32 | Length 320 mm | In distribution |
| GAP-CS3-22/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-N48-32 | Length 320 mm | In distribution |
| GAP-LG105/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-CS4-45/GAP-WAS100 | Outer Diameter 4 mm | In distribution |
| GAP-CS3-26 | Length 26 mm | In distribution |
| GAP-CS2-70 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS2-24/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-LG070 | Length 70 mm | In distribution |
| GAP-N80-30 | Length 300 mm | In distribution |
| GAP-PLC110 | In distribution | |
| GAP-2N56-24 | Outer Diameter 5.6 mm | In distribution |
| GAP-2N64-16 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS4-75/GAP-WAS100 | Length 75 mm | In distribution |
| GAP-N64-20 | Length 200 mm | In distribution |
| GAP-LG065/GAP-SSN55 | Length 65 mm | In distribution |
| GAP-CS4-60 | Length 60 mm | In distribution |
| GAP-LG070/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-N48-30 | Outer Diameter 4.8 mm | In distribution |
| GAP-CS2-55/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-N64-16 | Outer Diameter 6.4 mm | In distribution |
| GAP-2N64-30 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS3-75 | Length 75 mm | In distribution |
| GAP-N72-18 | Outer Diameter 7.2 mm | In distribution |
| GAP-N72-16 | Length 160 mm | In distribution |
| GAP-CS4-60/GAP-WAS100 | Length 60 mm | In distribution |
| GAP-2N72-32 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS2-26/GAP-WAS100 | Outer Diameter 2.5 mm | In distribution |
| GAP-CS4-45 | Length 45 mm | In distribution |
| GAP-CS3-65 | Length 65 mm | In distribution |
| GAP-CS3-70/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-2N48-30 | Length 300 mm | In distribution |
| GAP-CS2-60 | Outer Diameter 2.5 mm | In distribution |
| GAP-2N80-30 | Outer Diameter 8.0 mm | In distribution |
| GAP-N48-24 | Length 240 mm | In distribution |
| GAP-CS3-50/GAP-WAS100 | Length 50 mm | In distribution |
| GAP-2N64-22 | Outer Diameter 6.4 mm | In distribution |
| GAP-CS3-40 | Length 40 mm | In distribution |
| GAP-CS3-70 | Length 70 mm | In distribution |
| GAP-2N56-32 | Length 320 mm | In distribution |
| GAP-CS4-20/GAP-WAS100 | Length 20 mm | In distribution |
| GAP-CS3-36 | Outer Diameter 3 mm | In distribution |
| GAP-LG100/GAP-SSN55 | Outer Diameter 5.5 mm | In distribution |
| GAP-N72-26 | Length 260 mm | In distribution |
| GAP-IMF100 | In distribution | |
| GAP-CS3-65/GAP-WAS100 | Outer Diameter 3 mm | In distribution |
| GAP-2N72-28 | Outer Diameter 7.2 mm | In distribution |
| GAP-CS2-36/GAP-WAS100 | Length 36 mm | In distribution |
| GAP-CS4-32 | Length 32 mm | In distribution |
| GAP-2N56-22 | Outer Diameter 5.6 mm | In distribution |
| GAP-2N48-26 | Length 260 mm | In distribution |
| GAP-CP015 | Height 1.5 mm | In distribution |
| GAP-2N64-20 | Outer Diameter 6.4 mm | In distribution |
| GAP-N64-32 | Outer Diameter 6.4 mm | In distribution |
| GAP-2N56-26 | Outer Diameter 5.6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
Recalls
5 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 |
|---|---|---|---|---|---|
| 2019-05-29 | Class II | Component design/selection | Handle could jam with the Driver due to the detachment of an internal Connector Ring. | 19 | 2021-01-15 |
| 2015-04-10 | Class II | Nonconforming Material/Component | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, | 9 units (5 units in the US and 4 units international) | 2015-06-29 |
| 2015-02-20 | Class II | Other | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher | 7 units distributed in the US; | 2015-04-30 |
| 2014-03-05 | Class II | Error in labeling | The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. | 48 | 2014-05-19 |
| 2014-02-07 | Class II | Nonconforming Material/Component | The Male Components in this lot are made of material with lower strength than manufacturing specifications. | Total of 5 units (2 units in the US and 3 units in Germany) | 2014-04-23 |
| 2010-01-29 | Not classified | Process control | Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than t | 4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm) d | 2011-03-26 |
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.