Arix Pectus Bar System
Arix Pectus Bar System supports surgical repair of pectus excavatum and other anterior chest-wall deformities. It combines a pectus bar with a stabilizer to elevate the sternum. The bar is…
Arix Pectus Bar System supports surgical repair of pectus excavatum and other anterior chest-wall deformities. It combines a pectus bar with a stabilizer to elevate the sternum. The bar is inserted into the thoracic cavity and fixed to the ribs during a minimally invasive procedure.
The range offers single-bar, double-bar and multibar configurations according to the connection method. In a single-bar construct, only the lower bar may be used. The upper bar is not intended for use alone.
System Components
Accessories assist insertion and fixation of the bar during chest-wall repair. The bar and stabilizer work as parts of the reconstructive assembly, with the connection arrangement determining the permitted combination. These components are intended for correcting the thoracic deformity rather than replacing a rib or sternum.
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 | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K242751 |
| Record published | 2025-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PUP-350-TI | In distribution | |
| PUP-290-TI | In distribution | |
| PUP-310-TI | In distribution | |
| PUP-170-TI | In distribution | |
| PLO-190-TI | In distribution | |
| PBR-080-TI | In distribution | |
| PBR-060-TI | In distribution | |
| PUP-160-TI | In distribution | |
| PLO-290-TI | In distribution | |
| PUP-240-TI | In distribution | |
| PLO-240-TI | In distribution | |
| PLO-300-TI | In distribution | |
| PLO-390-TI | In distribution | |
| PLO-180-TI | In distribution | |
| PLO-330-TI | In distribution | |
| PUP-220-TI | In distribution | |
| PLO-170-TI | In distribution | |
| PLO-220-TI | In distribution | |
| PLO-230-TI | In distribution | |
| PLO-360-TI | In distribution | |
| PLO-270-TI | In distribution | |
| PUP-190-TI | In distribution | |
| PUP-180-TI | In distribution | |
| PLO-250-TI | In distribution | |
| PUP-340-TI | In distribution | |
| PUP-320-TI | In distribution | |
| PLO-340-TI | In distribution | |
| PLO-320-TI | In distribution | |
| PLO-310-TI | In distribution | |
| PLO-200-TI | In distribution | |
| PUP-270-TI | In distribution | |
| PUP-200-TI | In distribution | |
| PBR-100-TI | In distribution | |
| PBR-140-TI | In distribution | |
| PLO-400-TI | In distribution | |
| PLO-260-TI | In distribution | |
| PLO-160-TI | In distribution | |
| PLO-350-TI | In distribution | |
| PUP-280-TI | In distribution | |
| PUP-230-TI | In distribution | |
| PBR-160-TI | In distribution | |
| PLO-370-TI | In distribution | |
| PST-TI | In distribution | |
| PLO-280-TI | In distribution | |
| PLO-210-TI | In distribution | |
| PUP-330-TI | In distribution | |
| PSC-TI | In distribution | |
| PBR-120-TI | In distribution | |
| PUP-380-TI | In distribution | |
| PUP-250-TI | In distribution | |
| PLO-380-TI | In distribution | |
| PUP-360-TI | In distribution | |
| PUP-300-TI | In distribution | |
| PUP-260-TI | In distribution | |
| PUP-370-TI | In distribution | |
| PUP-210-TI | 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 |
|---|---|
| K242751 | 2025-05-30 |
| K231887 | 2023-12-14 |
| K231441 | 2023-07-17 |
| K230938 | 2023-05-03 |
| K221412 | 2022-11-22 |
| K221920 | 2022-08-24 |
| K202912 | 2020-10-29 |
| K201656 | 2020-09-15 |
| K193616 | 2020-03-04 |
| K191972 | 2019-11-12 |
| K181806 | 2018-11-20 |
| K180972 | 2018-10-03 |
| K172008 | 2017-12-01 |
| K170705 | 2017-09-21 |
| K170979 | 2017-08-17 |
| K170780 | 2017-08-14 |
| K170313 | 2017-07-27 |
| K171285 | 2017-07-24 |
| K161746 | 2016-09-21 |
| K161864 | 2016-08-02 |
| K151468 | 2016-01-14 |
| K132876 | 2013-12-18 |
| K131566 | 2013-11-04 |
| K131311 | 2013-09-05 |
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.