Synergy D2 Spinal Implants
by Interpore Cross Intl. 510(k)
Active
510(k) K984578
Overview
The Synergy D2 Spinal Implants are a posterior spinal fixation system designed for surgical fusion procedures. This device includes rods, pedicle screws, variable locking screws, iliac screws, hooks, transverse connectors, and lateral connectors to provide temporary stabilization of the spine during the healing process.
The system is intended for use in orthopedic surgical settings and is supplied as a reusable medical device. It has received FDA 510(k) clearance under the Traditional review pathway, with a clearance date of March 23, 1999. Components are intended for single-use per patient procedure, though the device itself may be reused across multiple cases under sterile conditions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984578 | Date23 Mar 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- Withdrawn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
- MNI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Interpore Cross Intl.
Questions
Are the Synergy D2 Spinal Implants intended for repeated use across multiple patients, and if so, how should they be handled between cases?
No, the individual components like rods, pedicle screws, iliac screws, hooks, and connectors are designed for single-use per patient procedure. However, the overall Synergy D2 system itself is classified as reusable—meaning the reusable parts (e.g., the rod assembly) can be sterilized and reused across multiple cases, provided they are maintained under sterile conditions between uses. This distinction is critical for infection control and inventory management.
What types of connectors and fasteners are included in the Synergy D2 system, and how do they contribute to spinal stabilization?
The Synergy D2 system includes variable locking screws, iliac screws, hooks, transverse connectors, and lateral connectors alongside rods and pedicle screws. These components work together to provide temporary stabilization by securing vertebrae in place during spinal fusion. For example, hooks can anchor to the lamina or spinous process, while transverse connectors bridge between rods to distribute load and maintain alignment—critical for facilitating proper healing.
How does the Synergy D2 system differ from other spinal fixation systems in terms of its regulatory pathway?
The Synergy D2 system was cleared via the FDA’s 510(k) Traditional review pathway under product code MNI (Orthopedic Devices, Spinal Fixation Systems) and classified as substantially equivalent to a predicate device. This pathway was used because the system’s design—combining rods, screws, hooks, and connectors—was deemed comparable to existing spinal fixation technologies already on the market, rather than requiring a more rigorous premarket approval (PMA).
What surgical settings is the Synergy D2 Spinal Implants designed for, and what does ‘posterior spinal fixation’ entail?
The Synergy D2 system is intended exclusively for orthopedic surgical settings, specifically for posterior spinal fusion procedures. ‘Posterior fixation’ refers to surgical approaches accessing the spine from the back, where implants like rods and screws are affixed to the posterior elements (e.g., pedicles, laminae) to stabilize the spine. This contrasts with anterior approaches (e.g., via the abdomen) and is commonly used for conditions like degenerative disc disease, scoliosis, or post-laminectomy instability.