Tibiaxys
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are implanted using Newdeal locking…
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. All plates and screws are manufactured from titanium alloy. The medial right / lateral left tibial plate is delivered non sterile.
22manufacturers in China registered for this device type
30catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls 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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K073375 |
| Record published | 2017-10-09 |
| Record revised | 2025-11-20 (version 8) |
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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150110SND | 77mm length x 16mm width | In distribution |
| 150516SND | 68.7mm length x 9.5mm width | In distribution |
| 150120ND | 92.7mm length x 19.9mm width | In distribution |
| 150040SND | 71mm length x 24mm width | In distribution |
| 150040ND | 71mm length x 24mm width | In distribution |
| 150514SND | 48.7mm length x 9.5mm width | In distribution |
| 150240SND | 4.0mm diam. x 40mm length | In distribution |
| 150030SND | In distribution | |
| 150020SND | 92.7mm length x 19.9mm width | In distribution |
| 150200SND | 4.0mm diam. x 100mm length | In distribution |
| 150020ND | 92.7mm length x 19.9mm width | In distribution |
| 150260SND | 4.0mm diam. x 60mm length | In distribution |
| 150110ND | 77mm length x 16mm width | In distribution |
| 150280SND | 4.0mm diam. x 80mm length | In distribution |
| 150285SND | 4.0mm diam. x 85mm length | In distribution |
| 150246SND | 4.0mm diam. x 46mm length | In distribution |
| 150030ND | In distribution | |
| 150270SND | 4.0mm diam. x 70mm length | In distribution |
| 150290SND | 4.0mm diam. x 90mm length | In distribution |
| 150275SND | 4.0mm diam. x 75mm length | In distribution |
| 150120SND | 92.7mm length x 19.9mm width | In distribution |
| 150242SND | 4.0mm diam. x 42mm length | In distribution |
| 150010ND | 77mm length x 16mm width | In distribution |
| 150255SND | 4.0mm diam. x 55mm length | In distribution |
| 150130SND | 75.2mm length x 10.5mm width | In distribution |
| 150010SND | 77mm length x 16mm width | In distribution |
| 150130ND | 75.2mm length x 10.5mm width | In distribution |
| 150265SND | 4.0mm diam. x 65mm length | In distribution |
| 150250SND | 4.0mm diam. x 50mm length | In distribution |
| TIBIAXYSSET | Withdrawn |
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 |
|---|---|
| K093914 | 2011-04-14 |
| K093781 | 2010-01-22 |
| K083154 | 2009-07-10 |
| K091609 | 2009-06-30 |
| K073375 | 2008-02-21 |
| K070447 | 2007-03-29 |
| K063831 | 2007-02-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2022-01-04 | Class II | Process control | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 8 units (US) |
Recalls
5 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 | Closed |
|---|---|---|---|---|
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
| 2018-05-22 | Class II | Packaging change control | Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal. | 2019-11-04 |
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.