PTN Peritrochanteric Nail
142 catalogue numbers from 29328, listed by Biomet Orthopedics, United States, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
142catalogue numbers in this listing
4510(k) clearances naming this product 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K050118 |
| Record published | 2020-02-13 |
| Record revised | 2025-05-30 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-12-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 29328 | 11mm Ø 100mm Length | In distribution |
| 29331 | 11mm Ø 115mm Length | In distribution |
| 30239 | 11MM Ø 100MM LENGTH | In distribution |
| 30242 | 11MM Ø 115MM LENGTH | In distribution |
| 29281 | 11MM Ø 110MM LENGTH | In distribution |
| 28334 | 11MM Ø 340MM LENGTH | In distribution |
| 29258 | 11MM Ø 95MM LENGTH | In distribution |
| 29234 | 11MM Ø 75MM LENGTH | In distribution |
| 29928 | 11MM Ø 280MM LENGTH | In distribution |
| 29221 | 11MM Ø 110MM LENGTH | In distribution |
| 28820 | 10mm Ø 170mm Length | In distribution |
| 29233 | 11MM Ø 70MM LENGTH | In distribution |
| 30257 | 11MM Ø 90MM LENGTH | In distribution |
| 30252 | 11MM Ø 65MM LENGTH | In distribution |
| 28821 | 11MM Ø 170MM LENGTH | In distribution |
| 29352 | 11mm Ø 70mm Length | In distribution |
| 30259 | 11MM Ø 100MM LENGTH | In distribution |
| 29330 | 11mm Ø 110mm Length | In distribution |
| 29924 | 11MM Ø 240MM LENGTH | In distribution |
| 29220 | 11MM Ø 105MM LENGTH | In distribution |
| 29355 | 11MM Ø 85MM LENGTH | In distribution |
| 28813 | 13MM Ø 220MM LENGTH | In distribution |
| 29327 | 11MM Ø 95MM LENGTH | In distribution |
| 30232 | 11MM Ø 65MM LENGTH | In distribution |
| 30233 | 11MM Ø 70MM LENGTH | In distribution |
| 29930 | 11MM Ø 300MM LENGTH | In distribution |
| 29323 | 11MM Ø 75MM LENGTH | In distribution |
| 30238 | 11MM Ø 95MM LENGTH | In distribution |
| 29209 | 15MM LENGTH | In distribution |
| 29217 | 11MM Ø 90MM LENGTH | In distribution |
| 30258 | 11MM Ø 95MM LENGTH | In distribution |
| 30237 | 11MM Ø 90MM LENGTH | In distribution |
| 29272 | 11MM Ø 65MM LENGTH | In distribution |
| 28230 | 11MM Ø 300MM LENGTH | In distribution |
| 29253 | 11MM Ø 70MM LENGTH | In distribution |
| 30253 | 11MM Ø 70MM LENGTH | In distribution |
| 29353 | 11MM Ø 75MM LENGTH | In distribution |
| 29280 | 11MM Ø 105MM LENGTH | In distribution |
| 30243 | 11MM Ø 120MM LENGTH | In distribution |
| 29240 | 11MM Ø 105MM LENGTH | In distribution |
| 29351 | 11mm Ø 65mm Length | In distribution |
| 30235 | 11MM Ø 80MM LENGTH | In distribution |
| 29277 | 11MM Ø 90MM LENGTH | In distribution |
| 29273 | 11MM Ø 70MM LENGTH | In distribution |
| 29359 | 11mm Ø 105mm Length | In distribution |
| 29223 | 11MM Ø 120MM LENGTH | In distribution |
| 30240 | 11MM Ø 105MM LENGTH | In distribution |
| 30263 | 11MM Ø 120MM LENGTH | In distribution |
| 29236 | 11MM Ø 85MM LENGTH | In distribution |
| 28926 | 11MM Ø 260MM LENGTH | In distribution |
| 28924 | 11MM Ø 240MM LENGTH | In distribution |
| 29213 | 11MM Ø 70MM LENGTH | In distribution |
| 29275 | 11MM Ø 80MM LENGTH | In distribution |
| 29256 | 11MM Ø 85MM LENGTH | In distribution |
| 28244 | 11MM Ø 440MM LENGTH | In distribution |
| 28224 | 11MM Ø 240MM LENGTH | In distribution |
| 29261 | 11MM Ø 110MM LENGTH | In distribution |
| 28328 | 11MM Ø 280MM LENGTH | In distribution |
| 29361 | 11MM Ø 115MM LENGTH | In distribution |
| 28226 | 11MM Ø 260MM LENGTH | In distribution |
| 29324 | 11MM Ø 80MM LENGTH | In distribution |
| 29215 | 11MM Ø 80MM LENGTH | In distribution |
| 29237 | 11MM Ø 90MM LENGTH | In distribution |
| 29206 | 0MM LENGTH | In distribution |
| 29260 | 11MM Ø 105MM LENGTH | In distribution |
| 30255 | 11MM Ø 80MM LENGTH | In distribution |
| 29239 | 11MM Ø 100MM LENGTH | In distribution |
| 29216 | 11MM Ø 85MM LENGTH | In distribution |
| 28330 | 11MM Ø 300MM LENGTH | In distribution |
| 28823 | 13MM Ø 170MM LENGTH | In distribution |
| 28248 | 11MM Ø 480MM LENGTH | In distribution |
| 29321 | 11MM Ø 65MM LENGTH | In distribution |
| 14-429301 | 11MM Ø 65MM LENGTH | In distribution |
| 29329 | 11MM Ø 105MM LENGTH | In distribution |
| 30260 | 11MM Ø 105MM LENGTH | In distribution |
| 29222 | 11MM Ø 115MM LENGTH | In distribution |
| 28324 | 11MM Ø 240MM LENGTH | In distribution |
| 28340 | 11MM Ø 400MM LENGTH | In distribution |
| 29243 | 11MM Ø 120MM LENGTH | In distribution |
| 29940 | 11MM Ø 400MM LENGTH | In distribution |
| 29235 | 11MM Ø 80MM LENGTH | In distribution |
| 29263 | 11MM Ø 120MM LENGTH | In distribution |
| 29208 | 10MM LENGTH | In distribution |
| 29238 | 11MM Ø 95MM LENGTH | In distribution |
| 29219 | 11MM Ø 100MM LENGTH | In distribution |
| 29276 | 11MM Ø 85MM LENGTH | In distribution |
| 29242 | 11MM Ø 115MM LENGTH | In distribution |
| 29325 | 11mm Ø 85mm Length | In distribution |
| 29262 | 11MM Ø 115MM LENGTH | In distribution |
| 29212 | 11MM Ø 65MM LENGTH | In distribution |
| 29356 | 11mm Ø 90mm Length | In distribution |
| 29259 | 11MM Ø 100MM LENGTH | In distribution |
| 28326 | 11MM Ø 260MM LENGTH | In distribution |
| 30236 | 11MM Ø 85MM LENGTH | In distribution |
| 28234 | 11MM Ø 340MM LENGTH | In distribution |
| 28242 | 11MM Ø 420MM LENGTH | In distribution |
| 28236 | 11MM Ø 360MM LENGTH | In distribution |
| 29214 | 11MM Ø 75MM LENGTH | In distribution |
| 29232 | 11MM Ø 65MM LENGTH | In distribution |
| 28240 | 11MM Ø 400MM LENGTH | In distribution |
| 28346 | 11MM Ø 460MM LENGTH | In distribution |
| 29357 | 11MM Ø 95MM LENGTH | In distribution |
| 28238 | 11MM Ø 380MM LENGTH | In distribution |
| 29354 | 11MM Ø 80MM LENGTH | In distribution |
| 28246 | 11MM Ø 460MM LENGTH | In distribution |
| 28232 | 11MM Ø 320MM LENGTH | In distribution |
| 30234 | 11MM Ø 75MM LENGTH | In distribution |
| 28342 | 11MM Ø 420MM LENGTH | In distribution |
| 29279 | 11MM Ø 100MM LENGTH | In distribution |
| 30254 | 11MM Ø 75MM LENGTH | In distribution |
| 29322 | 11MM Ø 70MM LENGTH | In distribution |
| 28348 | 11MM Ø 480MM LENGTH | In distribution |
| 29254 | 11MM Ø 75MM LENGTH | In distribution |
| 28344 | 11MM Ø 440MM LENGTH | In distribution |
| 29252 | 11MM Ø 65MM LENGTH | In distribution |
| 29283 | 11MM Ø 120MM LENGTH | In distribution |
| 29326 | 11MM Ø 90MM LENGTH | In distribution |
| 29278 | 11MM Ø 95MM LENGTH | In distribution |
| 29218 | 11MM Ø 95MM LENGTH | In distribution |
| 28336 | 11MM Ø 360MM LENGTH | In distribution |
| 29241 | 11MM Ø 110MM LENGTH | In distribution |
| 28811 | 11MM Ø 220MM LENGTH | In distribution |
| 30261 | 11MM Ø 110MM LENGTH | In distribution |
| 29282 | 11MM Ø 115MM LENGTH | In distribution |
| 29360 | 11mm Ø 110mm Length | In distribution |
| 30241 | 11MM Ø 110MM LENGTH | In distribution |
| 29255 | 11MM Ø 80MM LENGTH | In distribution |
| 29274 | 11MM Ø 75MM LENGTH | In distribution |
| 29936 | 11MM Ø 360MM LENGTH | In distribution |
| 29358 | 11mm Ø 100mm Length | In distribution |
| 28332 | 11MM Ø 320MM LENGTH | In distribution |
| 28338 | 11MM Ø 380MM LENGTH | In distribution |
| 29257 | 11MM Ø 90MM LENGTH | In distribution |
| 30262 | 11MM Ø 115MM LENGTH | In distribution |
| 28810 | 10mm Ø 220mm Length | In distribution |
| 29926 | 11MM Ø 260MM LENGTH | In distribution |
| 29207 | 5MM LENGTH | In distribution |
| 28228 | 11MM Ø 280MM LENGTH | In distribution |
| 30256 | 11MM Ø 85MM LENGTH | In distribution |
| 14-429312 | 11MM Ø 120MM LENGTH | Withdrawn |
| 14-429308 | 11MM Ø 100MM LENGTH | Withdrawn |
| 14-429310 | 11MM Ø 110MM LENGTH | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070955 | 2007-10-12 |
| K013923 | 2002-02-25 |
| K002278 | 2000-10-23 |
| K002057 | 2000-10-04 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2016-04-01 | Class II | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it ma | 2017-05-23 | |
| Biomet, Inc. | 510(k) number | 2012-03-30 | Not classified | Labeling mix-ups | The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation | 30 units in total | 2013-03-08 |
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.