OSSIOfiber® Compression Screw
OSSIOfiber Compression Screws are partially threaded, cannulated implants for maintaining bone alignment and fixation. They are used for fractures, fragments, osteotomies, arthrodesis and…
OSSIOfiber Compression Screws are partially threaded, cannulated implants for maintaining bone alignment and fixation. They are used for fractures, fragments, osteotomies, arthrodesis and bone grafts in the specified upper extremity and lower limb locations with appropriate bracing or immobilization.
The screws combine a degradable PLDLA polymer with continuous mineral fibers. Polymer hydrolysis produces compounds metabolized by the body, while the fiber minerals are also found in natural bone. The implant transfers load to the surrounding anatomy as it degrades during healing.
Listed Item
OSSIOfiber® Compression Screw, 3.5X30 mm. Package contains: 1 Implant.
Screw Configuration
The 3.5 mm screw range includes lengths from 14 to 50 mm. Screws are supplied sterile for a single patient and are designed for use with compatible commonly available orthopedic instruments. Indicated lower limb locations include the fibula, knee, ankle and foot.
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 | Ossio Ltd., Israel |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K213596 |
| Record published | 2023-02-20 |
| Record revised | 2024-03-22 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 7 to 30 °C; Special storage condition: Keep dry; Special storage condition: Store at a normal relative humidity; Special storage condition: Do not expose product to temperatures greater than 47°C or 116°F |
| Sizes | Outer diameter 3.5 to 4 mm; length 12 to 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OF1073530S | Outer Diameter 3.5 mm | In distribution |
| OF1024046S | Outer Diameter 4.0 mm | In distribution |
| OF1024058S | Outer Diameter 4.0 mm | In distribution |
| OF1073512S | Outer Diameter 3.5 mm | In distribution |
| OF1024052S | Outer Diameter 4.0 mm | In distribution |
| OF1024038S | Outer Diameter 4.0 mm | In distribution |
| OF1073518S | Outer Diameter 3.5 mm | In distribution |
| OF1024030S | Outer Diameter 4.0 mm | In distribution |
| OF1073516S | Outer Diameter 3.5 mm | In distribution |
| OF1073514S | Outer Diameter 3.5 mm | In distribution |
| OF1024034S | Outer Diameter 4.0 mm | In distribution |
| OF1073538S | Outer Diameter 3.5 mm | In distribution |
| OF1024032S | Outer Diameter 4.0 mm | In distribution |
| OF1024054S | Length 54 mm | In distribution |
| OF1024056S | Outer Diameter 4.0 mm | In distribution |
| OF1073520S | Outer Diameter 3.5 mm | In distribution |
| OF1024042S | Outer Diameter 4.0 mm | In distribution |
| OF1073528S | Outer Diameter 3.5 mm | In distribution |
| OF1073526S | Outer Diameter 3.5 mm | In distribution |
| OF1073532S | Outer Diameter 3.5 mm | In distribution |
| OF1024048S | Outer Diameter 4.0 mm | In distribution |
| OF1073540S | Outer Diameter 3.5 mm | In distribution |
| OF1073536S | Outer Diameter 3.5 mm | In distribution |
| OF1024028S | Outer Diameter 4.0 mm | In distribution |
| OF1024044S | Outer Diameter 4.0 mm | In distribution |
| OF1024060S | Outer Diameter 4.0 mm | In distribution |
| OF1024040S | Outer Diameter 4.0 mm | In distribution |
| OF1024026S | Outer Diameter 4.0 mm | In distribution |
| OF1073522S | Outer Diameter 3.5 mm | In distribution |
| OF1024036S | Outer Diameter 4.0 mm | In distribution |
| OF1073524S | Outer Diameter 3.5 mm | In distribution |
| OF1073534S | Outer Diameter 3.5 mm | In distribution |
| OF1024050S | Outer Diameter 4.0 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 |
|---|---|
| K254077 | 2026-05-01 |
| K241277 | 2024-07-03 |
| K233198 | 2024-03-08 |
| K221193 | 2022-12-23 |
| K213596 | 2021-12-21 |
| K193660 | 2020-07-30 |
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.