Intertan MAX
The INTERTAN MAX lag/compression screw kit is a fixation component for Smith+Nephew’s TRIGEN INTERTAN intramedullary nail system. The nail sits within the femur’s central canal, while the…
The INTERTAN MAX lag/compression screw kit is a fixation component for Smith+Nephew’s TRIGEN INTERTAN intramedullary nail system. The nail sits within the femur’s central canal, while the paired screws pass through the nail’s proximal locking arrangement to help secure the fracture construct.
The filed kit names a dynamic 120 mm lag screw and a 115 mm compression screw. In the INTERTAN design, the paired arrangement allows compression across the fracture while maintaining a fixed-angle relationship; this kit is not the complete nail assembly.
Listed Item
Intertan MAX LAG/Comp Screw KIT – Dynamic – 120MM/115MM
How the Kit Fits the Nail System
The manufacturer’s surgical technique distinguishes a compression insertion sequence from a no-compression configuration. That mechanism belongs to the paired proximal screws working through the nail, while the nail itself provides the intramedullary support. The manufacturer’s patient overview describes the broader nail-and-screw relationship; the filed kit remains one component of that system.
3manufacturers in China registered for this device type
235catalogue numbers in this listing
12510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JDS |
| Device type | Nail, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K240061 |
| Record published | 2025-11-11 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Angle 125 to 130 °; length 17.2 to 46 cm; length 35 to 125 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72911124L | Angle 130 ° | In distribution |
| 72900936L | Diameter: 9 mm | In distribution |
| 72910905 | Angle 130 ° | In distribution |
| 72911336L | Length 36 cm | In distribution |
| 72901040L | Diameter: 10 mm | In distribution |
| 72910944R | Angle 130 ° | In distribution |
| 72901140L | Length 40 cm | In distribution |
| 72912085 | Length 80 mm | In distribution |
| 72901126R | Length 26 cm | In distribution |
| 72901138R | Body side: RIGHT | In distribution |
| 72911130L | Body side: LEFT | In distribution |
| 72901044R | Diameter: 10 mm | In distribution |
| 72911026L | Body side: LEFT | In distribution |
| 72911044L | Length 44 cm | In distribution |
| 72901026L | Angle 125 ° | In distribution |
| 72901034L | Body side: LEFT | In distribution |
| 72900936R | Body side: RIGHT | In distribution |
| 72901030L | Length 30 cm | In distribution |
| 72911332R | Body side: RIGHT | In distribution |
| 72901130L | Length 30 cm | In distribution |
| 72910940R | Diameter: 9 mm | In distribution |
| 72911344L | Body side: LEFT | In distribution |
| 72900928L | Diameter: 9 mm | In distribution |
| 72900930R | Diameter: 9 mm | In distribution |
| 72910942L | Body side: LEFT | In distribution |
| 72911024R | Diameter: 10 mm | In distribution |
| 72912090 | Length 85 mm | In distribution |
| 72901346R | Angle 125 ° | In distribution |
| 72911346L | Diameter: 13 mm | In distribution |
| 72911142R | Body side: RIGHT | In distribution |
| 72900903 | Length 17.2 cm | In distribution |
| 72913080 | Length 80 mm | In distribution |
| 72901028L | Length 28 cm | In distribution |
| 72910944L | Body side: LEFT | In distribution |
| 72900906 | Diameter: 11.5 mm | In distribution |
| 72911142L | Angle 130 ° | In distribution |
| 72910936L | Angle 130 ° | In distribution |
| 72900924R | Diameter: 9 mm | In distribution |
| 72901326L | Body side: LEFT | In distribution |
| 72910906 | Angle 130 ° | In distribution |
| 72910926R | Body side: RIGHT | In distribution |
| 72910942R | Diameter: 9 mm | In distribution |
| 72913085 | Length 80 mm | In distribution |
| 72911334R | Angle 130 ° | In distribution |
| 72901336R | Length 36 cm | In distribution |
| 72911338L | Body side: LEFT | In distribution |
| 72901346L | Body side: LEFT | In distribution |
| 72911030L | Diameter: 10 mm | In distribution |
| 72900932R | Body side: RIGHT | In distribution |
| 72900944R | Body side: RIGHT | In distribution |
| 72901342L | Length 42 cm | In distribution |
| 72911334L | Body side: LEFT | In distribution |
| 72901334L | Angle 125 ° | In distribution |
| 72911326R | Body side: RIGHT | In distribution |
| 72912115 | Length 115 mm | In distribution |
| 72911128L | Angle 130 ° | In distribution |
| 72901342R | Angle 125 ° | In distribution |
| 72913100 | Length 95 mm | In distribution |
| 72912035 | Length 35 mm | In distribution |
| 72900905 | Angle 125 ° | In distribution |
| 72911342R | Body side: RIGHT | In distribution |
| 72920004 | In distribution | |
| 72910924L | Angle 130 ° | In distribution |
| 72913075 | Length 70 mm | In distribution |
| 72911340L | Length 40 cm | In distribution |
| 72911028R | Angle 130 ° | In distribution |
| 72901036L | Diameter: 10 mm | In distribution |
| 72911126L | Body side: LEFT | In distribution |
| 72911038L | Body side: LEFT | In distribution |
| 72911046L | Body side: LEFT | In distribution |
| 72901026R | Diameter: 10 mm | In distribution |
| 72910946R | Length 46 cm | In distribution |
| 72910902 | Length 19.5 cm | In distribution |
| 72901334R | Diameter: 13 mm | In distribution |
| 72910938R | Length 38 cm | In distribution |
| 72900940R | Length 40 cm | In distribution |
| 72912120 | Length 115 mm | In distribution |
| 72911132R | Diameter: 11.5 mm | In distribution |
| 72910932R | Body side: RIGHT | In distribution |
| 72911032L | Body side: LEFT | In distribution |
| 72911336R | Angle 130 ° | In distribution |
| 72913120 | Length 115 mm | In distribution |
| 72901136L | Length 36 cm | In distribution |
| 72911136R | Length 36 cm | In distribution |
| 72901036R | Body side: RIGHT | In distribution |
| 72911136L | Diameter: 11.5 mm | In distribution |
| 72901338R | Angle 125 ° | In distribution |
| 72913070 | Length 65 mm | In distribution |
| 72911032R | Length 32 cm | In distribution |
| 72901046L | Diameter: 10 mm | In distribution |
| 72901332L | Angle 125 ° | In distribution |
| 72900930L | Angle 125 ° | In distribution |
| 72900904 | Length 19.2 cm | In distribution |
| 72901132R | Diameter: 11.5 mm | In distribution |
| 72912080 | Length 75 mm | In distribution |
| 72900942L | Body side: LEFT | In distribution |
| 72910936R | Length 36 cm | In distribution |
| 72901046R | Length 46 cm | In distribution |
| 72911332L | Angle 130 ° | In distribution |
| 72901330R | Diameter: 13 mm | In distribution |
| 72911330L | Length 30 cm | In distribution |
| 72911034R | Angle 130 ° | In distribution |
| 72901326R | Body side: RIGHT | In distribution |
| 72911344R | Body side: RIGHT | In distribution |
| 72920014 | In distribution | |
| 72901338L | Body side: LEFT | In distribution |
| 72900926L | Angle 125 ° | In distribution |
| 72911034L | Length 34 cm | In distribution |
| 72900928R | Body side: RIGHT | In distribution |
| 72900938L | Body side: LEFT | In distribution |
| 72911132L | Angle 130 ° | In distribution |
| 72911028L | Body side: LEFT | In distribution |
| 72912125 | Length 125 mm | In distribution |
| 72910901 | Diameter: 9 mm | In distribution |
| 72911328R | Diameter: 13 mm | In distribution |
| 72910938L | Diameter: 9 mm | In distribution |
| 72901034R | Diameter: 10 mm | In distribution |
| 72911134L | Length 34 cm | In distribution |
| 72900934R | Body side: RIGHT | In distribution |
| 72910903 | Angle 130 ° | In distribution |
| 72901136R | Diameter: 11.5 mm | In distribution |
| 72911128R | Body side: RIGHT | In distribution |
| 72920009 | In distribution | |
| 72911042R | Diameter: 10 mm | In distribution |
| 72913105 | Length 105 mm | In distribution |
| 72911138R | Body side: RIGHT | In distribution |
| 72911036R | Angle 130 ° | In distribution |
| 72920012 | In distribution | |
| 72911144L | Length 44 cm | In distribution |
| 72901038R | Diameter: 10 mm | In distribution |
| 72911040L | Angle 130 ° | In distribution |
| 72901038L | Length 38 cm | In distribution |
| 72911038R | Diameter: 10 mm | In distribution |
| 72900944L | Diameter: 9 mm | In distribution |
| 72911126R | Diameter: 11.5 mm | In distribution |
| 72901134R | Length 34 cm | In distribution |
| 72901130R | Angle 125 ° | In distribution |
| 72910926L | Body side: LEFT | In distribution |
| 72901344L | Length 44 cm | In distribution |
| 72900942R | Length 42 cm | In distribution |
| 72900940L | Body side: LEFT | In distribution |
| 72901146L | Body side: LEFT | In distribution |
| 72911130R | Body side: RIGHT | In distribution |
| 72913110 | Length 110 mm | In distribution |
| 72911044R | Body side: RIGHT | In distribution |
| 72913090 | Length 90 mm | In distribution |
| 72912105 | Length 105 mm | In distribution |
| 72920010 | In distribution | |
| 72912095 | Length 95 mm | In distribution |
| 72910946L | Diameter: 9 mm | In distribution |
| 72911342L | Length 42 cm | In distribution |
| 72901328L | Angle 125 ° | In distribution |
| 72911036L | Angle 130 ° | In distribution |
| 72920006 | Angle 130 ° | In distribution |
| 72911146L | Angle 130 ° | In distribution |
| 72901032L | Angle 125 ° | In distribution |
| 72900946R | Length 46 cm | In distribution |
| 72911046R | Diameter: 10 mm | In distribution |
| 72901044L | Angle 125 ° | In distribution |
| 72910930R | Body side: RIGHT | In distribution |
| 72910928R | Angle 130 ° | In distribution |
| 72912075 | Length 75 mm | In distribution |
| 72901126L | Angle 125 ° | In distribution |
| 72913115 | Length 115 mm | In distribution |
| 72911140R | Diameter: 11.5 mm | In distribution |
| 72901024L | Angle 125 ° | In distribution |
| 72901330L | Angle 125 ° | In distribution |
| 72910924R | Length 24 cm | In distribution |
| 72912070 | Length 65 mm | In distribution |
| 72901032R | Body side: RIGHT | In distribution |
| 72911144R | Angle 130 ° | In distribution |
| 72910928L | Diameter: 9 mm | In distribution |
| 72901146R | Body side: RIGHT | In distribution |
| 72901328R | Body side: RIGHT | In distribution |
| 72911024L | Length 24 cm | In distribution |
| 72901332R | Diameter: 13 mm | In distribution |
| 72911326L | Body side: LEFT | In distribution |
| 72901124R | Angle 125 ° | In distribution |
| 72910932L | Body side: LEFT | In distribution |
| 72901142L | Angle 125 ° | In distribution |
| 72901142R | Length 42 cm | In distribution |
| 72920015 | In distribution | |
| 72900938R | Length 38 cm | In distribution |
| 72911026R | Angle 130 ° | In distribution |
| 72913095 | Length 95 mm | In distribution |
| 72901340R | Length 40 cm | In distribution |
| 72911338R | Diameter: 13 mm | In distribution |
| 72910904 | Length 19.5 cm | In distribution |
| 72901132L | Body side: LEFT | In distribution |
| 72911140L | Body side: LEFT | In distribution |
| 72911042L | Angle 130 ° | In distribution |
| 72911134R | Body side: RIGHT | In distribution |
| 72901336L | Body side: LEFT | In distribution |
| 72900924L | Length 24 cm | In distribution |
| 72901128L | Body side: LEFT | In distribution |
| 72911040R | Angle 130 ° | In distribution |
| 72911030R | Length 30 cm | In distribution |
| 72911138L | Angle 130 ° | In distribution |
| 72901144L | Length 44 cm | In distribution |
| 72920003 | In distribution | |
| 72901042L | Diameter: 10 mm | In distribution |
| 72900902 | Length 19.2 cm | In distribution |
| 72900932L | Diameter: 9 mm | In distribution |
| 72901144R | Length 44 cm | In distribution |
| 72912100 | Length 100 mm | In distribution |
| 72901124L | Length 24 cm | In distribution |
| 72900901 | Angle 125 ° | In distribution |
| 72901030R | Angle 125 ° | In distribution |
| 72900946L | Body side: LEFT | In distribution |
| 72912110 | Length 110 mm | In distribution |
| 72901128R | Angle 125 ° | In distribution |
| 72901024R | Diameter: 10 mm | In distribution |
| 72900934L | Length 34 cm | In distribution |
| 72910930L | Length 30 cm | In distribution |
| 72920005 | Angle 125 ° | In distribution |
| 72901040R | Body side: RIGHT | In distribution |
| 72920011 | In distribution | |
| 72901134L | Body side: LEFT | In distribution |
| 72901138L | Diameter: 11.5 mm | In distribution |
| 72901340L | Length 40 cm | In distribution |
| 72911346R | Angle 130 ° | In distribution |
| 72901042R | Diameter: 10 mm | In distribution |
| 72910934L | Length 34 cm | In distribution |
| 72901028R | Body side: RIGHT | In distribution |
| 72910940L | Diameter: 9 mm | In distribution |
| 72911124R | Angle 130 ° | In distribution |
| 72911340R | Diameter: 13 mm | In distribution |
| 72911146R | Body side: RIGHT | In distribution |
| 72901344R | Diameter: 13 mm | In distribution |
| 72911328L | Body side: LEFT | In distribution |
| 72911330R | Diameter: 13 mm | In distribution |
| 72913125 | Length 120 mm | In distribution |
| 72901140R | Angle 125 ° | In distribution |
| 72900926R | Body side: RIGHT | In distribution |
| 72910934R | Angle 130 ° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Autobahn | Globus Medical, Inc. | 1,102 |
| Trigen | Smith & Nephew, Inc. | 1,062 |
| Nail, Fixation, Bone | Synthes Gmbh | 296 |
| Nail, Fixation, Bone | Synthes (U.S.A.) LP | 237 |
| EXPert Nail | Synthes Gmbh | 225 |
| Trigen MAX | Smith & Nephew, Inc. | 172 |
| Ajax Nail | Auxein medical Private limited | 168 |
| GPC | GPC Medical Limited | 155 |
| 130° Ga-mma Nail | Auxein medical Private limited | 90 |
| Ender Nail | Smith & Nephew, Inc. | 82 |
| Centronail Titanium Humeral Nailing System | Orthofix SRL | 79 |
| Expert Femoral Nail | Auxein medical Private limited | 70 |
Showing 12 of 112. All products under Nail, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243608 | 2025-06-12 |
| K240061 | 2024-09-20 |
| K241804 | 2024-08-22 |
| K230761 | 2023-06-14 |
| K123948 | 2013-03-14 |
| K061783 | 2006-08-10 |
| K061019 | 2006-06-06 |
| K051557 | 2005-06-30 |
| K050938 | 2005-05-04 |
| K040212 | 2004-02-20 |
| K983942 | 1998-12-04 |
| K981529 | 1998-07-09 |
Recalls
8 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 |
|---|---|---|---|---|---|
| 2020-11-02 | Class II | Packaging process control | Manufacturing packaging error. | 41 units | 2023-01-06 |
| 2020-06-24 | Class II | Reprocessing Controls | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. | 12 units | 2021-04-28 |
| 2017-10-24 | Class II | Employee error | A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. | 17 units | |
| 2014-07-02 | Class II | Under Investigation by firm | There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. | 601 units | 2019-08-20 |
| 2014-04-04 | Class II | Process control | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | 1,253 units total | 2017-07-01 |
| 2014-04-04 | Class II | Process control | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | 1,253 units total | 2017-07-01 |
| 2013-02-07 | Class II | Labeling mix-ups | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. | 90 units | 2016-01-11 |
| 2013-02-07 | Class II | Labeling mix-ups | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. | 69 units | 2016-01-11 |
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.