Mathis Vertebral and Bone Biopsy System
by International Medical Systems
510(k) K990515
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990515 | Date13 May 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1075
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Mathis Vertebral and Bone Biopsy System is a manual biopsy instrument designed for obtaining bone marrow samples. It consists of a cannula with a sharpened distal tip and a coaxial stylet, both insert-molded to threaded hubs with lug tabs for secure attachment. This system is classified under Instrument, Biopsy (Product Code KNW) and is intended for use in clinical procedures requiring precise bone penetration.
The system is operated manually by physicians in clinical settings and includes a removable, gripable handle for controlled application. Supplied as a reusable device, it requires proper sterilization between uses. Authorized under FDA 510(k) clearance (K990515), the system adheres to Class II special controls and was reviewed by the Gastroenterology and Urology Advisory Committee. No MRI safety or single-use specifications are indicated.
Other devices from International Medical Systems
Questions
AI-generated answers, 19 Sep 2026
Is the Mathis Vertebral and Bone Biopsy System intended for single-use or can it be reused after proper sterilization?
The Mathis Vertebral and Bone Biopsy System is designed as a reusable device, meaning it must undergo proper sterilization between uses to ensure safety and efficacy. This is explicitly stated in the device description, which notes it is operated manually by physicians in clinical settings and does not mention single-use specifications.
How is the Mathis Vertebral and Bone Biopsy System regulated in the U.S.? What committee reviewed it?
The system is regulated under the FDA 510(k) clearance process (K990515) and is classified as Class II with special controls. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee in 1999, as indicated by the advisory committee description and decision documentation. The clearance type is traditional, meaning it was evaluated for substantial equivalence to a predicate device.
What components make up the Mathis Vertebral and Bone Biopsy System, and how are they assembled?
The system consists of a cannula with a sharpened distal tip and a coaxial stylet, both insert-molded to threaded hubs with lug tabs for secure attachment. These components are designed to work together for precise bone penetration, and the system includes a removable, gripable handle for controlled manual operation by physicians.
What types of bone procedures is this system intended for, and how is it classified?
The Mathis Vertebral and Bone Biopsy System is classified under Product Code KNW (Instrument, Biopsy) and is intended for obtaining bone marrow samples in clinical procedures requiring precise bone penetration. While the system is not explicitly tied to a specific clinical indication, its design and classification align with procedures like bone marrow aspiration or vertebral biopsy.
Does the Mathis Vertebral and Bone Biopsy System have any special considerations for storage or handling?
The device description does not specify storage conditions, but as a reusable, manually operated system, it should be stored in a clean, dry environment to prevent contamination. Since it requires sterilization between uses, proper handling and maintenance of the threaded hubs and handle are critical to ensure functionality and sterility. Always follow manufacturer guidelines for cleaning and sterilization protocols.