OSSIOfiber® Hammertoe Fixation System
The OSSIOfiber Hammertoe Fixation System uses a ribbed implant placed between the proximal and middle toe phalanges. Its ribs engage the phalangeal canal to maintain alignment and fixation…
The OSSIOfiber Hammertoe Fixation System uses a ribbed implant placed between the proximal and middle toe phalanges. Its ribs engage the phalangeal canal to maintain alignment and fixation during bone healing, with appropriate additional immobilization.
The implant combines degradable PLDLA polymer with continuous mineral fibers. As it degrades, load transfers to the surrounding anatomy. The polymer breaks down by hydrolysis into compounds metabolized by the body, while the fibers contain minerals found in natural bone.
Listed Item
The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, straight 0°. Package contains: 1 K-wire, 1 Drill Bit, 1 Inserter, 1 Implant straight 0°.
Sterile Procedure Kit
The sterile kit contains an implant premounted on an inserter, a drill bit and a K wire. Implant options include straight and 10 degree forms, with lengths from 16 to 21 mm and nominal diameters from 2.5 to 3.2 mm.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Ossio Ltd., Israel |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K190652 |
| Record published | 2020-03-12 |
| Record revised | 2023-09-18 (version 2) |
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 | Special storage condition: Do not expose product to temperatures greater than 47°C or 116°F.; Special storage condition: Store at a normal relative humidity; Special storage condition: Keep dry; Storage environment temperature 7 to 30 °C |
| Sizes | Outer diameter 2.5 to 3.2 mm; length 16 to 21 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OF20025161 | Outer Diameter 2.5 mm | In distribution |
| OF20032211 | Outer Diameter 3.2 mm | In distribution |
| OF20029190 | Outer Diameter 2.9 mm | In distribution |
| OF20025160 | Outer Diameter 2.5 mm | In distribution |
| OF20029191 | Outer Diameter 2.9 mm | In distribution |
| OF20032210 | Outer Diameter 3.2 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231272 | 2023-12-01 |
| K230750 | 2023-09-13 |
| K203465 | 2021-01-06 |
| K201803 | 2020-10-16 |
| K190652 | 2020-03-06 |
| K181180 | 2019-01-10 |
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.