Precice® Intramedullary Limb Lengthening System
Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 10.7 mm Diameter, 160 mm
17manufacturers in China registered for this device type
596catalogue numbers in this listing
18510(k) clearances naming this product code
9recalls 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 | NuVasive Specialized Orthopedics, Inc., United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K172628 |
| Record published | 2015-10-15 |
| Record revised | 2026-02-09 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Storage environment humidity 5 to 95 % RH |
| Sizes | Outer diameter 3.5 to 12.5 mm; lumen/inner diameter 4 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P10.7-80D365 | Outer Diameter 10.7 mm | In distribution |
| P003 | In distribution | |
| P8.5-50B230 | Outer Diameter 8.5 mm | In distribution |
| LSB5-020 | Outer Diameter 5.0 mm | In distribution |
| LSC5-060 | Outer Diameter 5.0 mm | In distribution |
| P10.7-80X275 | Outer Diameter 10.7 mm | In distribution |
| P10.7-80E365 | Outer Diameter 10.7 mm | In distribution |
| P8.5-80E365 | Outer Diameter 8.5 mm | In distribution |
| P8.5-50N150 | Outer Diameter 8.5 mm | In distribution |
| PR9.5-80D335 | Outer Diameter 9.5 mm | In distribution |
| TSA4.5-425-S | Diameter, 4.5mm | In distribution |
| LSC4-050 | Outer Diameter 4.0 mm | In distribution |
| TSA4-000-S | Diameter, 5.0mm | In distribution |
| PR9.5-80A275 | Outer Diameter 9.5 mm | In distribution |
| TSA4-047.5 | Outer Diameter 4.0 mm | In distribution |
| TSA4.5-400-S | Diameter, 4.5mm | In distribution |
| PR11.5-80B335 | Outer Diameter 11.5 mm | In distribution |
| LSC5-020 | Outer Diameter 5.0 mm | In distribution |
| LSC4-045 | Outer Diameter 4.0 mm | In distribution |
| PR12.5-80A305 | Outer Diameter 12.5 mm | In distribution |
| P12.5-80C365 | Outer Diameter 12.5 mm | In distribution |
| P8.5-80A305 | Outer Diameter 8.5 mm | In distribution |
| TSA4-225-S | Diameter, 4.0mm | In distribution |
| ERC 2P | In distribution | |
| P003 | In distribution | |
| PR11.5-80E335 | Outer Diameter 11.5 mm | In distribution |
| PR11.5-50E230 | Outer Diameter 11.5 mm | In distribution |
| PR12.5-80E245 | Outer Diameter 12.5 mm | In distribution |
| P10.7-80A245 | Outer Diameter 10.7 mm | In distribution |
| PR11.5-80A245 | Outer Diameter 11.5 mm | In distribution |
| LSB4-035 | Outer Diameter 4.0 mm | In distribution |
| TSA4-022.5 | Outer Diameter 4.0 mm | In distribution |
| PR10.5-50E230 | Outer Diameter 10.5 mm | In distribution |
| P8.5-80V275 | Outer Diameter 8.5 mm | In distribution |
| P10.7-80X335 | Outer Diameter 10.7 mm | In distribution |
| TSA5-047.5 | Outer Diameter 5.0 mm | In distribution |
| P8.5-80V305 | Outer Diameter 8.5 mm | In distribution |
| TSA4.5-750-S | Diameter, 4.5mm | In distribution |
| PR10.5-50B215 | Outer Diameter 10.5 mm | In distribution |
| PR12.5-80C245 | Outer Diameter 12.5 mm | In distribution |
| P12.5-50B215 | Outer Diameter 12.5 mm | In distribution |
| ERC2P-LAPTOP_P_UK | Tool/Instrument | In distribution |
| P10.7-80B305 | Outer Diameter 10.7 mm | In distribution |
| PR12.5-50A230 | Outer Diameter 12.5 mm | In distribution |
| P8.5-80X275 | Outer Diameter 8.5 mm | In distribution |
| LSC5-075 | Outer Diameter 5.0 mm | In distribution |
| P10.7-80B245 | Outer Diameter 10.7 mm | In distribution |
| P10.7-50A230 | Outer Diameter 10.7 mm | In distribution |
| P8.5-80X365 | Outer Diameter 8.5 mm | In distribution |
| LSB4-045 | Outer Diameter 4.0 mm | In distribution |
| PR9.0-80B335 | Outer Diameter 9.0 mm | In distribution |
| PR11.5-80C245 | Outer Diameter 11.5 mm | In distribution |
| PR10.5-80E365 | Outer Diameter 10.5 mm | In distribution |
| ERC2P-LAPTOP_P_US | In distribution | |
| P10.7-50E230 | Outer Diameter 10.7 mm | In distribution |
| P12.5-80V245 | Outer Diameter 12.5 mm | In distribution |
| LSB4-020 | Outer Diameter 4.0 mm | In distribution |
| P12.5-50V230 | Outer Diameter 12.5 mm | In distribution |
| LSC5-085 | Outer Diameter 5.0 mm | In distribution |
| P10.7-50N160 | Outer Diameter 10.7 mm | In distribution |
| CPA1-000 | Outer Diameter 10.7 mm | In distribution |
| TSA4.5-450-S | Diameter, 4.5mm | In distribution |
| PR10.5-80B305 | Outer Diameter 10.5 mm | In distribution |
| TSA5-500-S | Diameter, 5.0mm | In distribution |
| P10.7-50H190 | Outer Diameter 10.7 mm | In distribution |
| LSB3-075 | Outer Diameter 3.5 mm | In distribution |
| PR9.5-50A215 | Outer Diameter 9.5 mm | In distribution |
| ERC2P-LAPTOP_P_AR | Tool/Instrument | In distribution |
| P12.5-80B305 | Outer Diameter 12.5 mm | In distribution |
| LSB5-060 | Outer Diameter 5.0 mm | In distribution |
| P8.5-50J180 | Outer Diameter 8.5 mm | In distribution |
| P12.5-30K170 | Outer Diameter 12.5 mm | In distribution |
| PR10.5-80C365 | Outer Diameter 10.5 mm | In distribution |
| TSA5-950-S | Diameter, 5.0mm | In distribution |
| P12.5-80D365 | Outer Diameter 12.5 mm | In distribution |
| P12.5-80A305 | Outer Diameter 12.5 mm | In distribution |
| P8.5-80C275 | Outer Diameter 8.5 mm | In distribution |
| LSC4-075 | Outer Diameter 5.0 mm | In distribution |
| PR9.0-80A245 | Outer Diameter 9.0 mm | In distribution |
| P10.7-50C230 | Outer Diameter 10.7 mm | In distribution |
| P10.7-50P175 | Outer Diameter 10.7 mm | In distribution |
| P10.7-30J160 | Outer Diameter 10.7 mm | In distribution |
| P12.5-80V335 | Outer Diameter 12.5 mm | In distribution |
| PR11.5-50A230 | Outer Diameter 11.5 mm | In distribution |
| PR10.5-80D305 | Outer Diameter 10.5 mm | In distribution |
| P10.7-80B335 | Outer Diameter 10.7 mm | In distribution |
| P8.5-80C365 | Outer Diameter 8.5 mm | In distribution |
| P10.7-80X365 | Outer Diameter 10.7 mm | In distribution |
| P8.5-50Q155 | Outer Diameter 8.5 mm | In distribution |
| P003 | In distribution | |
| PR9.0-80A305 | Outer Diameter 9.0 mm | In distribution |
| PR9.0-80A365 | Outer Diameter 9.0 mm | In distribution |
| P10.7-80C335 | Outer Diameter 10.7 mm | In distribution |
| PR9.0-80A275 | Outer Diameter 9.0 mm | In distribution |
| P8.5-80C335 | Outer Diameter 8.5 mm | In distribution |
| P003 | In distribution | |
| P8.5-80B335 | Outer Diameter 8.5 mm | In distribution |
| PR9.5-80E365 | Outer Diameter 9.5 mm | In distribution |
| TSA4-070 | Outer Diameter 4.0 mm | In distribution |
| PR10.5-50C215 | Outer Diameter 10.5 mm | In distribution |
| PR11.5-80C275 | Outer Diameter 11.5 mm | In distribution |
| PR12.5-80D365 | Outer Diameter 12.5 mm | In distribution |
| TSA4-060 | Outer Diameter 4.0 mm | In distribution |
| PR9.0-80D305 | Outer Diameter 9.0 mm | In distribution |
| HEC4-000 | Outer Diameter 8.5 mm | In distribution |
| HEC3-000 | Outer Diameter 8.5 mm | In distribution |
| PR9.5-80D305 | Outer Diameter 9.5 mm | In distribution |
| TSA4-040 | Outer Diameter 4.0 mm | In distribution |
| P003 | In distribution | |
| PR10.5-80A335 | Outer Diameter 10.5 mm | In distribution |
| P12.5-50H190 | Outer Diameter 12.5 mm | In distribution |
| P10.7-80C275 | Outer Diameter 10.7 mm | In distribution |
| P12.5-50A230 | Outer Diameter 12.5 mm | In distribution |
| PR10.5-80C305 | Outer Diameter 10.5 mm | In distribution |
| P8.5-50X230 | Outer Diameter 8.5 mm | In distribution |
| HEC5-000 | Outer Diameter 8.5 mm | In distribution |
| PR11.5-80E365 | Outer Diameter 11.5 mm | In distribution |
| PR12.5-80C335 | Outer Diameter 12.5 mm | In distribution |
| TSA4-050 | Outer Diameter 4.0 mm | In distribution |
| PR9.0-50D230 | Outer Diameter 9.0 mm | In distribution |
| TSA5-080 | Outer Diameter 5.0 mm | In distribution |
| LSC4-070 | Outer Diameter 5.0 mm | In distribution |
| PR12.5-80C275 | Outer Diameter 12.5 mm | In distribution |
| PR10.5-80C275 | Outer Diameter 10.5 mm | In distribution |
| PR9.5-80C335 | Outer Diameter 9.5 mm | In distribution |
| P12.5-80C275 | Outer Diameter 12.5 mm | In distribution |
| PR11.5-80D365 | Outer Diameter 11.5 mm | In distribution |
| P8.5-50D230 | Outer Diameter 8.5 mm | In distribution |
| PR12.5-50D215 | Outer Diameter 12.5 mm | In distribution |
| PR11.5-80D275 | Outer Diameter 11.5 mm | In distribution |
| LSC5-080 | Outer Diameter 5.0 mm | In distribution |
| PR11.5-80D335 | Outer Diameter 11.5 mm | In distribution |
| LSB4-025 | Outer Diameter 4.0 mm | In distribution |
| PR9.5-80C245 | Outer Diameter 9.5 mm | In distribution |
| PR9.5-50D215 | Outer Diameter 9.5 mm | In distribution |
| CPA3-000 | Outer Diameter 10.7 mm | In distribution |
| TSA4-850-S | Diameter, 4.0mm | In distribution |
| P8.5-30U170 | Outer Diameter 8.5 mm | In distribution |
| ERC 2P | In distribution | |
| LSC4-065 | Outer Diameter 5.0 mm | In distribution |
| P12.5-80X245 | Outer Diameter 12.5 mm | In distribution |
| LSC5-050 | Outer Diameter 5.0 mm | In distribution |
| P12.5-80V365 | Outer Diameter 12.5 mm | In distribution |
| PR11.5-80E275 | Outer Diameter 11.5 mm | In distribution |
| TSA4-020 | In distribution | |
| HEC2-000 | Outer Diameter 8.5 mm | In distribution |
| PR12.5-80E275 | Outer Diameter 12.5 mm | In distribution |
| TSA4.5-950-S | Diameter, 4.5mm | In distribution |
| P8.5-50A230 | Outer Diameter 8.5 mm | In distribution |
| P8.5-80V335 | Outer Diameter 8.5 mm | In distribution |
| P8.5-80D275 | Outer Diameter 8.5 mm | In distribution |
| P10.7-30K170 | Outer Diameter 10.7 mm | In distribution |
| LSC5-040 | Outer Diameter 5.0 mm | In distribution |
| TSA5-650-S | In distribution | |
| P12.5-80D305 | Outer Diameter 12.5 mm | In distribution |
| P8.5-80A275 | Outer Diameter 8.5 mm | In distribution |
| PR10.5-80A365 | Outer Diameter 10.5 mm | In distribution |
| P8.5-80C305 | Outer Diameter 8.5 mm | In distribution |
| TSA4.5-025 | Outer Diameter 4.5 mm | In distribution |
| P10.7-80D245 | Outer Diameter 10.7 mm | In distribution |
| P10.7-50A215 | Outer Diameter 10.7 mm | In distribution |
| PR11.5-80A335 | Outer Diameter 11.5 mm | In distribution |
| PR9.0-50C195 | Outer Diameter 9.0 mm | In distribution |
| PR9.5-80A305 | Outer Diameter 9.5 mm | In distribution |
| TSA5-032.5 | Outer Diameter 5.0 mm | In distribution |
| TSA4.5-600-S | Diameter, 4.5mm | In distribution |
| LSC4-040 | Outer Diameter 4.0 mm | In distribution |
| P12.5-50X230 | Outer Diameter 12.5 mm | In distribution |
| PR12.5-80B335 | Outer Diameter 12.5 mm | In distribution |
| LSC4-080 | In distribution | |
| P10.7-30H170 | Outer Diameter 10.7 mm | In distribution |
| TSA4-325-S | Diameter, 4.0mm | In distribution |
| PR11.5-80A365 | Outer Diameter 11.5 mm | In distribution |
| PR9.0-80C275 | Outer Diameter 9.0 mm | In distribution |
| P8.5-80V245 | Outer Diameter 8.5 mm | In distribution |
| ERC2P-LAPTOP UK | In distribution | |
| P8.5-80B365 | Outer Diameter 8.5 mm | In distribution |
| LSB4-040 | Outer Diameter 4.0 mm | In distribution |
| P10.7-50V230 | Outer Diameter 10.7 mm | In distribution |
| P12.5-80D335 | Outer Diameter 12.5 mm | In distribution |
| LSC5-090 | Outer Diameter 5.0 mm | In distribution |
| P10.7-80C305 | Outer Diameter 10.7 mm | In distribution |
| LSC4-020 | Outer Diameter 4.0 mm | In distribution |
| TSA4-030 | Outer Diameter 4.0 mm | In distribution |
| P8.5-30H170 | Outer Diameter 8.5 mm | In distribution |
| P12.5-50X215 | Outer Diameter 12.5 mm | In distribution |
| LSB5-030 | Outer Diameter 5.0 mm | In distribution |
| LSB3-060 | Outer Diameter 3.5 mm | In distribution |
| TSA4.5-075 | Outer Diameter 4.5 mm | In distribution |
| P003 | In distribution | |
| P12.5-80E365 | Outer Diameter 12.5 mm | In distribution |
| TSA5-325-S | Diameter, 5.0mm | In distribution |
| P10.7-80D275 | Outer Diameter 10.7 mm | In distribution |
| TSA4-042.5 | Outer Diameter 4.0 mm | In distribution |
| PR10.5-80A245 | Outer Diameter 10.5 mm | In distribution |
| TSA5-275-S | Diameter, 5.0mm | In distribution |
| TSA4-100 | Outer Diameter 4.0 mm | In distribution |
| TSA5-045 | Outer Diameter 5.0 mm | In distribution |
| P10.7-80D305 | Outer Diameter 10.7 mm | In distribution |
| LSB3-065 | In distribution | |
| PR9.0-50B215 | Outer Diameter 9.0 mm | In distribution |
| P8.5-80D335 | Outer Diameter 8.5 mm | In distribution |
| PR9.0-80D245 | Outer Diameter 9.0 mm | In distribution |
| PR10.5-50A230 | Outer Diameter 10.5 mm | In distribution |
| P10.7-30U170 | Outer Diameter 10.7 mm | In distribution |
| P8.5-80X305 | Outer Diameter 8.5 mm | In distribution |
| TSA4.5-060 | Outer Diameter 4.5 mm | In distribution |
| P10.7-50D230 | Outer Diameter 10.7 mm | In distribution |
| TSA5-085 | Outer Diameter 5.0 mm | In distribution |
| PR11.5-50A215 | Outer Diameter 11.5 mm | In distribution |
| P10.7-50B230 | Outer Diameter 10.7 mm | In distribution |
| PR12.5-50D230 | Outer Diameter 12.5 mm | In distribution |
| P12.5-80B245 | Outer Diameter 12.5 mm | In distribution |
| PR12.5-50E215 | Outer Diameter 12.5 mm | In distribution |
| TSA4-035 | Outer Diameter 4.0 mm | In distribution |
| PR9.0-80E335 | Outer Diameter 9.0 mm | In distribution |
| TSA4.5-550-S | Diameter, 4.5mm | In distribution |
| TSA4-600-S | Diameter, 4.0mm | In distribution |
| PR12.5-80D305 | Outer Diameter 12.5 mm | In distribution |
| PR10.5-80E245 | Outer Diameter 10.5 mm | In distribution |
| P003 | In distribution | |
| PR12.5-50C230 | Outer Diameter 12.5 mm | In distribution |
| P8.5-50M165 | Outer Diameter 8.5 mm | In distribution |
| TSA4.5-650-S | Diameter, 4.5mm | In distribution |
| LSB3-025 | Outer Diameter 3.5 mm | In distribution |
| PR11.5-80C335 | Outer Diameter 11.5 mm | In distribution |
| P10.7-80A365 | Outer Diameter 10.7 mm | In distribution |
| TSA4.5-020 | Outer Diameter 4.5 mm | In distribution |
| TSA5-400-S | Diameter, 5.0mm | In distribution |
| PR9.5-80A245 | Outer Diameter 9.5 mm | In distribution |
| PR12.5-50B230 | Outer Diameter 12.5 mm | In distribution |
| P10.7-50D215 | Outer Diameter 10.7 mm | In distribution |
| PR11.5-50C195 | Outer Diameter 11.5 mm | In distribution |
| TSA4-300-S | Diameter, 4.0mm | In distribution |
| P10.7-80E335 | Outer Diameter 10.7 mm | In distribution |
| PR9.5-80B365 | Outer Diameter 9.5 mm | In distribution |
| PR10.5-50C230 | Outer Diameter 10.5 mm | In distribution |
| PR9.0-80E245 | Outer Diameter 9.0 mm | In distribution |
| PR10.5-80D245 | Outer Diameter 10.5 mm | In distribution |
| TSA5-025 | Outer Diameter 5.0 mm | In distribution |
| TSA5-850-S | Diameter, 5.0mm | In distribution |
| P8.5-50V230 | Outer Diameter 8.5 mm | In distribution |
| P8.5-80E275 | Outer Diameter 8.5 mm | In distribution |
| LSC5-035 | Outer Diameter 5.0 mm | In distribution |
| CPA2-000 | Outer Diameter 8.5 mm | In distribution |
| P003 | In distribution | |
| PR9.0-80D275 | Outer Diameter 9.0 mm | In distribution |
| P12.5-80A245 | Outer Diameter 12.5 mm | In distribution |
| LSB5-075 | Outer Diameter 5.0 mm | In distribution |
| TSA5-100 | Outer Diameter 5.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261651 | 2026-06-18 |
| K232267 | 2023-12-15 |
| K230765 | 2023-08-29 |
| K220234 | 2023-03-15 |
| K202348 | 2020-12-22 |
| K200430 | 2020-09-16 |
| K201567 | 2020-08-10 |
| K193617 | 2020-05-08 |
| K193016 | 2020-05-08 |
| K191336 | 2019-09-26 |
| K182170 | 2019-02-05 |
| K180503 | 2018-04-03 |
| K173129 | 2017-12-01 |
| K172628 | 2017-09-25 |
| K172061 | 2017-08-24 |
| K170169 | 2017-06-09 |
| K162927 | 2017-04-06 |
| K170346 | 2017-03-07 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| NuVasive Specialized Orthopedics, Inc. | UDI-DI | 2021-02-12 | Class II | Device Design | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. | 10,657 units |
| NuVasive Specialized Orthopedics, Inc. | UDI-DI | 2021-02-12 | Class II | Device Design | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. | 59 units |
Recalls
7 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 |
|---|---|---|---|---|
| 2024-09-30 | Class II | Under Investigation by firm | Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. | 164 devices |
| 2021-10-29 | Class II | Device Design | The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no | Total 11,861 devices (IMLL=10,657 and Short=1,204) |
| 2021-02-12 | Class II | Under Investigation by firm | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. | 40 units |
| 2021-02-12 | Class II | Under Investigation by firm | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. | 226 units |
| 2021-02-12 | Class II | Under Investigation by firm | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. | 2360 units |
| 2021-02-12 | Class II | Device Design | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. | 229 units |
| 2020-07-24 | Class II | Device Design | During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. | 41 total units |
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.