B-Twin Bone Expander System (B-Twin BE System)
by Disc-O-Tech Medical Technologies, Ltd. 510(k)
Active
510(k) K032358
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032358 | Date17 Dec 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The B-Twin Bone Expander System (B-Twin BE System) is a mechanical surgical device classified as a bone tamp, designed to create or reduce voids within cancellous bone. It features an expandable tube mounted on a delivery system, which is inserted in a reduced 5-mm diameter configuration and then expanded in situ to achieve the desired effect. This system is intended for orthopedic applications where controlled bone manipulation is required. The expandable mechanism allows precise void formation or fracture reduction within the bone structure.
The B-Twin BE System is supplied as a surgical instrument set and is intended for use in clinical settings by trained surgeons. It is not specified as single-use or reusable in the provided data, though its design suggests it may be intended for single-patient use. The device carries an FDA 510(k) clearance under K032358, classified under the HRX product code for orthopedic devices. No additional sterility, MRI safety, or storage specifications are provided in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the B-TWIN Bone Expander System used for?
The B-TWIN Bone Expander System is designed to create or reduce voids within cancellous bone during orthopedic procedures. Its expandable tube, delivered in a compact 5-mm diameter configuration, allows surgeons to manipulate bone precisely in situ—ideal for fracture reduction or void formation where controlled bone shaping is required.
How is the B-TWIN BE System supplied, and what does the set include?
The B-TWIN BE System is supplied as a complete surgical instrument set, intended for use in clinical environments by trained surgeons. The system includes the expandable tube and delivery mechanism, but no additional details on specific components or accessories are provided in the available data.
Is the B-TWIN Bone Expander System intended for single-use or reuse?
The provided data does not explicitly state whether the B-TWIN BE System is single-use or reusable. However, its design—particularly the expandable mechanism—suggests it is likely intended for single-patient use to maintain sterility and prevent cross-contamination between procedures.
What regulatory clearance does the B-TWIN Bone Expander System hold?
The B-TWIN BE System holds FDA 510(k) clearance under the reference number K032358, classified under the HRX product code for orthopedic devices. This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate, allowing it to enter the U.S. market.
Are there any special storage or sterility requirements for the B-TWIN BE System?
The available data does not specify any particular sterility requirements or storage conditions for the B-TWIN BE System. As with most surgical instruments, proper sterilization protocols (e.g., autoclave or ethylene oxide) should be followed if the device is reused, though its intended use may lean toward single-patient applications to ensure sterility.