CurvaFix® Low Profile Implant
CurvaFix Low Profile Implant is a flexible intramedullary device for pelvic fracture fixation. It has a threaded, self-tapping distal end and a proximal interface for applying driving…
CurvaFix Low Profile Implant is a flexible intramedullary device for pelvic fracture fixation. It has a threaded, self-tapping distal end and a proximal interface for applying driving torque.
After insertion, an integral shape-lock mechanism changes the implant from flexible to rigid. The mechanism can return the implant to a flexible state if removal is required.
Listed Item
The CurvaFix Low Profile Implant is an implantable intramedullary device for pelvic fracture fixation. The devices have a threaded, self-tapping distal end and a driving torque interface at the proximal end. An integral shape lock feature changes the CurvaFix Implant from a flexible to rigid state after implantation. The CurvaFix Implant can be returned to a flexible state should device explant be required. Supplied individually on a backer card in a sterile barrier package placed in shelf carton. The device is manufactured from Stainless Steel.
Sizes and Accessories
Implants are available in 7.5 and 9.5 mm diameters and lengths from 90 to 210 mm. Two washer options distribute load where bone quality is poor. Dedicated instruments and accessories support placement, with implant size and construct selected for the pelvic anatomy and fracture.
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Curvafix, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K252019 |
| Record published | 2025-10-22 |
| Record revised | 2026-06-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 7.5 to 9.5 mm; length 90 to 210 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9.5 mm x 90 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 180 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 150 mm | Outer Diameter 9.5 mm | In distribution |
| 7.5 mm x 130 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 90 mm | Outer Diameter 7.5 mm | In distribution |
| 9.5 mm x 190 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 140 mm | Outer Diameter 9.5 mm | In distribution |
| 7.5 mm x 110 mm | Length 110 mm | In distribution |
| 9.5 mm x 110 mm | Length 110 mm | In distribution |
| 7.5 mm x 190 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 210 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 170 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 200 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 100 mm | Outer Diameter 7.5 mm | In distribution |
| 9.5 mm x 210 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 160 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 130 mm | Outer Diameter 9.5 mm | In distribution |
| 7.5 mm x 140 mm | Outer Diameter 7.5 mm | In distribution |
| 9.5 mm x 200 mm | Outer Diameter 9.5 mm | In distribution |
| 9.5 mm x 100 mm | Outer Diameter 9.5 mm | In distribution |
| 7.5 mm x 150 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 120 mm | Outer Diameter 7.5 mm | In distribution |
| 9.5 mm x 120 mm | Outer Diameter 9.5 mm | In distribution |
| 7.5 mm x 180 mm | Outer Diameter 7.5 mm | In distribution |
| 7.5 mm x 160 mm | Outer Diameter 7.5 mm | In distribution |
| 9.5 mm x 170 mm | Outer Diameter 9.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252019 | 2025-08-29 |
| K222505 | 2022-10-27 |
| K180050 | 2019-03-01 |
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.