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Sign in to claim this brandBioscience, Inc.
US
Last updated May 23, 2026
What Bioscience, Inc. makes
Bioscience, Inc. manufactures biodegradable orthopedic fixation devices made from self-reinforced poly-L-lactide (SR-PLLA). These include absorbable tacks for soft tissue attachment, a meniscus repair arrow system, and threaded fixation rods designed to dissolve over time after stabilizing bone or cartilage.
The company’s products are classified as Class II devices under FDA regulations and are authorised via the 510(k) pathway. They are based in the United States and their devices are listed in the FDA’s 510(k) registry.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioscience, Inc. manufacture?
Bioscience, Inc. specializes in biodegradable orthopedic fixation devices made from self-reinforced poly-L-lactide (SR-PLLA). These include absorbable tacks for securing soft tissues, a meniscus repair arrow system, and threaded fixation rods. All products are designed to dissolve over time after performing their stabilization function, eliminating the need for surgical removal.
Where is Bioscience, Inc. based, and what regulatory pathway do its devices follow?
Bioscience, Inc. is headquartered in the United States. Its devices are classified as Class II under FDA regulations, which means they pose moderate risk and require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
Which regulatory registries list Bioscience, Inc.’s devices?
Bioscience, Inc.’s devices are listed in the FDA’s 510(k) registry, where they are documented as authorised via the 510(k) premarket submission process. This registry provides transparency on the device’s classification, intended use, and regulatory clearance status.
How are Bioscience, Inc.’s devices classified by the FDA?
The FDA classifies Bioscience, Inc.’s devices as Class II. This classification is based on the moderate risk associated with orthopedic fixation products, requiring manufacturers to demonstrate safety and effectiveness through the 510(k) pathway—proving their devices are substantially equivalent to a legally marketed predicate.
What is the primary material used in Bioscience, Inc.’s fixation devices?
The primary material used in Bioscience, Inc.’s fixation devices is self-reinforced poly-L-lactide (SR-PLLA), a biodegradable polymer. This material is chosen for its ability to provide mechanical stability while gradually dissolving in the body after fulfilling its fixation purpose, reducing the need for secondary surgical interventions.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LivRing(R) | VR101 | FDA UDI | Class II | Active |
| Biofix Absorbable Self-Reinforced Poly-L-Lactide | K925098 | FDA 510(k) | Class II | Active |
| Biofix Biodegradable Self-Reinforced Poly-L-Lactide (sr-Plla) Mini-Tack | K955003 | FDA 510(k) | Class II | Active |
| VR101 Lubricating Intravaginal Ring | K203377 | FDA 510(k) | Class II | Active |
| Biofix Biodegradable Meniscus Arrow System | K955768 | FDA 510(k) | Class II | Active |
| Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod | K952471 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- BioScience GmbH DE