AnyPlus II Spinal Fixation System
by GS Medical Co., Ltd. 2 variants
510(k) K240350
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240350 | Date3 Apr 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- Withdrawn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
- 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, 19 Sep 2026
The AnyPlus II Spinal Fixation System is a posterior spinal fixation device designed for internal fixation of the spine. It includes pedicle screw fixation components for the thoracic (T1–S2) and lumbar (T1–L5) regions, as well as posterior hook fixation (T1–L5) and anterolateral fixation (T8–L5) options. The system is intended for skeletally mature patients requiring surgical stabilization of the spine.
The system is supplied as a modular set of reusable surgical instruments and single-use implants, including self-tapping, cannulated polyaxial screws and preloaded rods. Components are intended for use in sterile surgical environments, with MRI safety not specified. The system carries FDA 510(k) clearance under product code NKB, with a decision date of April 3, 2024. Storage and handling follow standard orthopedic surgical protocols.
Other devices from GS Medical Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What regions of the spine is the AnyPlus II Spinal Fixation System designed to stabilize, and what types of fixation options does it offer?
The AnyPlus II Spinal Fixation System is designed for stabilization of the thoracic (T1–S2) and lumbar (T1–L5) spine regions. It provides three types of fixation options: pedicle screw fixation for both thoracic and lumbar regions, posterior hook fixation (T1–L5), and anterolateral fixation (T8–L5). This modular design allows surgeons to choose the appropriate fixation method based on the patient’s anatomy and clinical needs.
Are the implants in the AnyPlus II system single-use or reusable, and how should they be handled during surgery?
The implants in the AnyPlus II Spinal Fixation System are single-use components, including self-tapping, cannulated polyaxial screws and preloaded rods. The reusable surgical instruments are separate from the implants. Since the implants are intended for sterile surgical environments, they must be handled according to standard orthopedic surgical protocols to maintain sterility and prevent contamination.
What types of screws are included in the AnyPlus II system, and how do they differ from one another?
The AnyPlus II system includes self-tapping, cannulated polyaxial screws designed for pedicle screw fixation. These screws are cannulated (hollow) to allow for over-the-wire insertion techniques, which can simplify placement in certain clinical scenarios. The polyaxial design allows for multiplanar adjustment, providing flexibility in alignment during spinal stabilization procedures.
How is the AnyPlus II Spinal Fixation System regulated in the U.S., and what does the FDA clearance under product code NKB indicate?
The AnyPlus II Spinal Fixation System holds FDA 510(k) clearance under product code NKB, which indicates it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance was granted by the Orthopedic (OR) Advisory Committee after review, with a decision date of April 3, 2024. The clearance does not imply any specific clinical indication but confirms compliance with regulatory requirements for spinal fixation devices.
What storage and handling guidelines should be followed for the AnyPlus II system to ensure proper functionality and sterility?
The AnyPlus II Spinal Fixation System follows standard orthopedic surgical protocols for storage and handling. Since the implants are single-use, they must be stored in a clean, dry environment as per manufacturer instructions to preserve sterility. Reusable instruments should be cleaned, disinfected, and sterilized according to established surgical instrument protocols to maintain their integrity and prevent cross-contamination between procedures.