Modification To Isola Spinal System
by Depuyacromed 510(k)
Active
510(k) K993030
Overview
The Modification To Isola Spinal System is a pedicle screw system designed to provide immobilization and stabilization of spinal segments in skeletally mature patients. It is used as an adjunct to spinal fusion to treat acute or chronic instability and deformity of the spine.
The device was cleared by the FDA through a traditional 510(k) submission (K993030) on 29 December 1999, classified as an Orthosis, Spinal Pedicle Fixation (product code KWQ) and subject to Class II special controls. It is supplied by Depuyacromed, Raynham, MA, United States, and is identified as a modification to the ISOLA Spinal System.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993030 | Date29 Dec 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- KWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Depuyacromed
Questions
What clinical purpose does the Modification to Isola Spinal System serve?
It provides immobilization and stabilization of spinal segments in skeletally mature patients, acting as an adjunct to spinal fusion to treat acute or chronic instability and deformity of the spine. By securing the vertebrae with pedicle screws, it helps maintain alignment while the fusion matures.
How is the device supplied and where is it manufactured?
The system is supplied by Depuyacromed, located at 325 Paramount Dr., Raynham, MA 02767, United States. The manufacturer’s contact listed is Frank Maas. This information indicates the product is distributed directly from the U.S. facility.
Is the Modification to Isola Spinal System intended for single‑use or multiple‑use?
The device is a pedicle screw system intended for implantation during a surgical procedure and is not designed for reuse. Implantable fixation hardware is typically considered single‑use because it remains permanently in the patient’s body after placement.
What sizes or models are available for this pedicle screw system?
The provided data does not list specific sizes or model variations; it only identifies the product as a modification to the ISOLA Spinal System. Clinicians should refer to the manufacturer’s catalog or labeling for detailed size options.
What regulatory clearance does this device have?
The Modification to Isola Spinal System received FDA 510(k) clearance (K993030) on 29 December 1999. It was classified as an Orthosis, Spinal Pedicle Fixation (product code KWQ) and is subject to Class II special controls, indicating it met the criteria for substantial equivalence to a legally marketed predicate device.