Trigen
Knee Fusion Femoral Antegrade Nail 11.5-10MM X 78CM With Step AT 57CM Right
3manufacturers in China registered for this device type
1,062catalogue 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) | K050938 |
| Record published | 2016-01-27 |
| Record revised | 2025-11-28 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Do Not Use If Packaging Damaged |
| Sizes | Length 85 to 100 mm |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XT001021-1 | In distribution | |
| 71931669 | In distribution | |
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| 71678090 | Length 90 mm | In distribution |
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| 71678095 | Diameter: 11 mm | In distribution |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Autobahn | Globus Medical, Inc. | 1,102 |
| Nail, Fixation, Bone | Synthes Gmbh | 296 |
| Nail, Fixation, Bone | Synthes (U.S.A.) LP | 237 |
| Intertan MAX | Smith & Nephew, Inc. | 235 |
| 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 Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smith & Nephew Orthopaedics AG | 510(k) number | 2022-04-22 | Class II | Under Investigation by firm | Right nails were anodized, marked, and labelled as left nails and vice versa | 17 units | |
| Smith & Nephew, Inc. | 510(k) number | 2020-11-02 | Class II | Packaging process control | Manufacturing packaging error. | 41 units | 2023-01-06 |
| Smith & Nephew, Inc. | 510(k) number | 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 |
| Smith & Nephew, Inc. | 510(k) number | 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 | |
| Smith & Nephew, Inc. | 510(k) number | 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 |
| Smith & Nephew, Inc. | 510(k) number | 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 |
| Smith & Nephew, Inc. | 510(k) number | 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 |
| Smith & Nephew, Inc. | 510(k) number | 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 |
| Smith & Nephew, Inc. | 510(k) number | 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 |
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.