OrthoPediatrics PediNail Intramedullary Nailing System
IM FEMORAL NAIL, 10mm x 30cm, Right
17manufacturers in China registered for this device type
83catalogue numbers in this listing
6510(k) clearances naming this product code
31recalls 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, Corp, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K083726 |
| Record published | 2015-09-01 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-1500-039 | In distribution | |
| 10-1500-101 | In distribution | |
| 10-1500-051 | In distribution | |
| 10-1500-023 | In distribution | |
| 10-1500-089 | In distribution | |
| 10-1500-091 | In distribution | |
| 10-1500-081 | In distribution | |
| 10-1500-037 | In distribution | |
| 10-1500-072 | In distribution | |
| 10-1500-086 | In distribution | |
| 10-1500-043 | In distribution | |
| 10-1500-019 | In distribution | |
| 10-1500-018 | In distribution | |
| 10-1500-090 | In distribution | |
| 10-1500-016 | In distribution | |
| 10-1500-078 | In distribution | |
| 10-1500-083 | In distribution | |
| 10-1500-041 | In distribution | |
| 10-1500-077 | In distribution | |
| 10-1500-034 | In distribution | |
| 10-1500-068 | In distribution | |
| 10-1500-096 | In distribution | |
| 10-1500-107 | In distribution | |
| 10-1500-079 | In distribution | |
| 10-1500-030 | In distribution | |
| 10-1500-047 | In distribution | |
| 10-1500-067 | In distribution | |
| 10-1500-045 | In distribution | |
| 10-1500-069 | In distribution | |
| 10-1500-027 | In distribution | |
| 10-1500-025 | In distribution | |
| 10-1500-046 | In distribution | |
| 10-1500-0015 | In distribution | |
| 10-1500-021 | In distribution | |
| 10-1500-087 | In distribution | |
| 10-1500-031 | In distribution | |
| 10-1500-054 | In distribution | |
| 10-1500-028 | In distribution | |
| 10-1500-097 | In distribution | |
| 10-1500-071 | In distribution | |
| 10-1500-044 | In distribution | |
| 10-1500-080 | In distribution | |
| 10-1500-053 | In distribution | |
| 10-1500-036 | In distribution | |
| 10-1500-0005 | In distribution | |
| 10-1500-104 | In distribution | |
| 10-1500-024 | In distribution | |
| 10-1500-076 | In distribution | |
| 10-1500-022 | In distribution | |
| 10-1500-0020 | In distribution | |
| 10-1500-032 | In distribution | |
| 10-1500-066 | In distribution | |
| 10-1500-106 | In distribution | |
| 10-1500-092 | In distribution | |
| 10-1500-029 | In distribution | |
| 10-1500-035 | In distribution | |
| 10-1500-095 | In distribution | |
| 10-1500-038 | In distribution | |
| 10-1500-056 | In distribution | |
| 10-1500-0010 | In distribution | |
| 10-1500-094 | In distribution | |
| 10-1500-017 | In distribution | |
| 10-1500-040 | In distribution | |
| 10-1500-082 | In distribution | |
| 10-1500-074 | In distribution | |
| 10-1500-055 | In distribution | |
| 10-1500-033 | In distribution | |
| 10-1500-103 | In distribution | |
| 10-1500-105 | In distribution | |
| 10-1500-084 | In distribution | |
| 10-1500-073 | In distribution | |
| 10-1500-042 | In distribution | |
| 10-1500-093 | In distribution | |
| 10-1500-075 | In distribution | |
| 10-1500-102 | In distribution | |
| 10-1500-088 | In distribution | |
| 10-1500-052 | In distribution | |
| 10-1500-098 | In distribution | |
| 10-1500-048 | In distribution | |
| 10-1500-085 | In distribution | |
| 10-1500-026 | In distribution | |
| 10-1500-057 | In distribution | |
| 10-1500-000 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250623 | 2025-04-01 |
| K231266 | 2023-08-21 |
| K220679 | 2022-07-20 |
| K190321 | 2019-10-09 |
| K172583 | 2018-05-10 |
| K083726 | 2009-03-11 |
Recalls Naming This Product
27 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 |
|---|---|---|---|---|---|---|---|
| Orthopediatrics, Corp | 510(k) number | 2016-11-18 | Class III | Labeling mix-ups | Labeled as a 48mm Cortical Screw but measuring at 50mm | 22 units | 2017-07-27 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| Orthopediatrics, Corp | 510(k) number | 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2019-08-19 | Class II | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | 969 total | 2020-04-30 |
| 2019-08-19 | Class II | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | 969 total | 2020-04-30 |
| 2019-08-19 | Class II | Device Design | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures | 211 units | 2020-10-26 |
| 2012-09-13 | Class II | Reprocessing Controls | A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | 78 | 2013-09-18 |
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.