Isola and Expedium Growing Spine Systems
by Medos Sarl
510(k) K141509
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141509 | Date22 Aug 2014 | 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- Withdrawn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
- PGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Isola and Expedium Growing Spine Systems are classified as Growing Rod Systems, designed to facilitate spinal growth correction in pediatric patients. These devices are intended for surgical use in managing severe, progressive spinal deformities such as early-onset scoliosis and thoracic insufficiency, enabling gradual spinal elongation while maintaining correction during growth phases.
The systems are supplied as orthopedic implants and are regulated under FDA 510(k) clearance (K141509) as substantially equivalent to predicate devices. They are intended for use in operating room settings and are not single-use; however, specific sterilization and handling instructions must be followed as per manufacturer guidelines. The systems include multiple reference codes (e.g., 3000270450, 3004142400) to identify distinct configurations or sizes. No MRI safety information or reusable status is explicitly stated in the provided data.
Questions
AI-generated answers, 1 Oct 2026
What are the Isola and Expedium Growing Spine Systems designed to treat?
These systems are specifically intended for surgical management of severe, progressive spinal deformities in pediatric patients, such as early-onset scoliosis and thoracic insufficiency. They are engineered to facilitate gradual spinal elongation while maintaining correction during the patient’s growth phases, helping to address deformities that develop or worsen as the child grows.
Are the Isola and Expedium systems single-use or reusable?
The Isola and Expedium Growing Spine Systems are not single-use devices. They are designed for reuse, but must be sterilized and handled according to the manufacturer’s guidelines to ensure safety and efficacy. Proper sterilization is critical to prevent contamination and maintain device integrity for subsequent procedures.
How are these systems supplied, and what reference codes identify them?
The systems are supplied as orthopedic implants in various configurations, each identified by distinct reference codes. Examples include 3000270450, 3004142400, and several others listed in the FDA records. These codes correspond to different sizes or components within the Isola and Expedium families, allowing clinicians to select the appropriate setup for a patient’s specific needs.
What regulatory clearance do these systems hold, and where were they submitted?
The Isola and Expedium Growing Spine Systems hold FDA 510(k) clearance under the reference number K141509. They were submitted to the Orthopedic (OR) Advisory Committee and are classified under product code PGM. The submission was filed in Raynham, Massachusetts, and the clearance was granted as substantially equivalent to predicate devices.
Can these systems be used in patients who require MRI scans?
The provided data does not explicitly state whether the Isola and Expedium Growing Spine Systems are MRI-safe. Clinicians should consult the manufacturer’s instructions or contact Medos Sarl directly for guidance on MRI compatibility, as improper imaging could pose risks to the patient or the device.