Pelvic Incidence (PI) Rod System
by Spinal Alignment Solutions, Inc.
510(k) K242350
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242350 | Date28 Oct 2024 | 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- Withdrawn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
- Full name
- Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
- 510(k) Number
- FDA Product Code
- NKB
- 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 Pelvic Incidence (PI) Rod System is a spinal fixation device designed for posterior, lumbar, and sacral fixation. It is intended for use in skeletally mature patients as an adjunct to spinal fusion, providing segmental alignment through six pre-contoured rods matched to patient-specific pelvic incidence categories. Each rod is engineered to reflect segmental lordosis distributions derived from clinical fusion outcome data, facilitating precise surgical planning and implant selection. This system falls under the orthopedic device category and is classified under product code NKB.
The system is supplied as a reusable surgical implant and is intended for use with the Medtronic CD Horizon SOLERA Spinal System. It has received FDA clearance through a 510(k) submission (K242350) under the Traditional review pathway, with a decision date of October 28, 2024. The rods are pre-contoured to align with specific pelvic incidence measurements, aiding in achieving optimal spinal curvature during surgical procedures. No additional sterility or single-use specifications are noted in the regulatory data.
Other devices from Spinal Alignment Solutions, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Pelvic Incidence (PI) Rod System used for?
The PI Rod System is designed as an adjunct to spinal fusion for posterior, lumbar, and sacral fixation in skeletally mature patients. Its six pre-contoured rods are tailored to patient-specific pelvic incidence categories, helping surgeons achieve segmental alignment that matches clinically derived lordosis distributions. This ensures more accurate surgical planning and implant selection for improved spinal curvature outcomes.
How is the PI Rod System supplied and intended for use?
The system is supplied as a reusable surgical implant, meaning it is intended for multiple uses in sterile conditions during surgical procedures. It is specifically designed to integrate with the Medtronic CD Horizon SOLERA Spinal System, allowing for compatibility with existing surgical workflows and instrumentation.
Are the rods single-use or reusable, and what does that mean for sterility?
The rods are reusable, which means they must be sterilized between uses in accordance with standard surgical protocols. Reusability implies they undergo rigorous cleaning and sterilization processes to maintain safety and efficacy, though no specific sterility claims (e.g., terminally sterilized) are noted in the regulatory data. Clinicians should follow manufacturer guidelines for sterilization and handling.
How are the rods differentiated by model or size?
The rods are differentiated by their pre-contoured designs, which correspond to specific pelvic incidence (PI) categories. Each rod is engineered to reflect segmental lordosis distributions derived from clinical fusion outcome data, ensuring alignment with a patient’s unique anatomical needs. The system does not list discrete size models beyond these PI-matched contours.
What regulatory pathway was followed for FDA clearance of this system?
The PI Rod System received FDA clearance through a 510(k) submission (K242350) under the Traditional review pathway, with a decision date of October 28, 2024. The submission was classified under product code NKB (Orthopedic) and was reviewed by the Orthopedic Devices Advisory Committee (OR). The determination was that the device is substantially equivalent to a legally marketed predicate.