OrthoPediatrics PediNail Intramedullary Nailing System
4.5 mm X 100 mm RECON LOCKING SCREW
22manufacturers in China registered for this device type
47catalogue numbers in this listing
15510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K083726 |
| Record published | 2015-09-01 |
| Record revised | 2025-07-08 (version 7) |
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 |
|---|---|---|
| 10-1500-3016 | In distribution | |
| 10-1500-4050 | In distribution | |
| 10-1500-4085 | In distribution | |
| 10-1500-3055 | In distribution | |
| 10-1500-3038 | In distribution | |
| 10-1500-2025 | In distribution | |
| 10-1500-4100 | In distribution | |
| 10-1500-4095 | In distribution | |
| 10-1500-3022 | In distribution | |
| 10-1500-3046 | In distribution | |
| 10-1500-3070 | In distribution | |
| 10-1500-3018 | In distribution | |
| 10-1500-2060 | In distribution | |
| 10-1500-3042 | In distribution | |
| 10-1500-3026 | In distribution | |
| 10-1500-2015 | In distribution | |
| 10-1500-3032 | In distribution | |
| 10-1500-4075 | In distribution | |
| 10-1500-4070 | In distribution | |
| 10-1500-2020 | In distribution | |
| 10-1500-3044 | In distribution | |
| 10-1500-3036 | In distribution | |
| 10-1500-4090 | In distribution | |
| 10-1500-4045 | In distribution | |
| 10-1500-2055 | In distribution | |
| 10-1500-3034 | In distribution | |
| 10-1500-3080 | In distribution | |
| 10-1500-2040 | In distribution | |
| 10-1500-2050 | In distribution | |
| 10-1500-3048 | In distribution | |
| 10-1500-3040 | In distribution | |
| 10-1500-4065 | In distribution | |
| 10-1500-4080 | In distribution | |
| 10-1500-4055 | In distribution | |
| 10-1500-3028 | In distribution | |
| 10-1500-3020 | In distribution | |
| 10-1500-2045 | In distribution | |
| 10-1500-3075 | In distribution | |
| 10-1500-3050 | In distribution | |
| 10-1500-2035 | In distribution | |
| 10-1500-2030 | In distribution | |
| 10-1500-3065 | In distribution | |
| 10-1500-3085 | In distribution | |
| 10-1500-4060 | In distribution | |
| 10-1500-3060 | In distribution | |
| 10-1500-3030 | In distribution | |
| 10-1500-3024 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260323 | 2026-04-30 |
| K252600 | 2025-10-09 |
| K243963 | 2025-04-29 |
| K190992 | 2019-08-06 |
| K172425 | 2017-12-06 |
| K171173 | 2017-08-24 |
| K162307 | 2016-09-27 |
| K140431 | 2014-07-29 |
| K110959 | 2011-08-05 |
| K111086 | 2011-06-17 |
| K100240 | 2010-05-17 |
| K090666 | 2009-04-24 |
| K083286 | 2009-01-30 |
| K081407 | 2008-07-22 |
| K073344 | 2008-02-19 |
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 |
|---|---|---|---|---|---|
| 2015-07-28 | Class II | Packaging process control | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. | 5 | 2016-03-17 |
| 2013-09-26 | Class II | Labeling mix-ups | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined | 7 units shipped | 2013-12-26 |
| 2012-10-18 | Class II | Nonconforming Material/Component | Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not fun | 24 | 2013-09-18 |
| 2012-06-14 | Class II | Error in labeling | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. | 15 devices | 2013-04-30 |
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.