AccuLIF TL and PL Cage
by Stryker Corporation 4 variants
510(k) K152651
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152651 | Date15 Dec 2015 | 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- Withdrawn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
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The AccuLIF TL and PL Cage is an expandable interbody fusion device designed for lumbar spine surgery. Constructed from a titanium alloy cage, silicone rubber components, and a hydraulic expansion system (including tubing and a pressure syringe), it is intended for spinal stabilization and fusion procedures. This device falls under the classification of an orthopedic interbody fusion system, facilitating vertebral body alignment and bone growth across the intervertebral space. Its expandable design allows for precise sizing and placement within the spinal column.
The AccuLIF TL and PL Cage is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K152651) as a Class II orthopedic product (product code MAX). It is intended for use in surgical settings where lumbar spinal fusion is performed, requiring appropriate sterile techniques. The device is available in specific sizes tailored for lumbar interbody applications, with the titanium alloy cage providing structural integrity and the hydraulic system enabling controlled expansion. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Other devices from Stryker Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the AccuLIF TL and PL Cage used for?
The AccuLIF TL and PL Cage is designed for lumbar spine surgery to facilitate spinal stabilization and fusion. Its expandable titanium alloy cage, combined with silicone rubber components and a hydraulic expansion system, allows precise sizing and placement within the intervertebral space. This promotes vertebral body alignment and supports bone growth across the treated area, aiding in long-term spinal stability.
How is the AccuLIF TL and PL Cage supplied and what are its sterility and reuse details?
The AccuLIF TL and PL Cage is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining device integrity. Due to its single-use nature, reuse is not recommended or permitted, as it could compromise sterility and structural reliability.
What materials are used in the AccuLIF TL and PL Cage, and why?
The device is constructed from a titanium alloy cage, silicone rubber components, and a hydraulic expansion system (including tubing and a pressure syringe). Titanium alloy provides structural strength and biocompatibility, while silicone rubber components enhance durability and flexibility. The hydraulic system enables controlled expansion for precise placement during surgery.
What sizes are available for the AccuLIF TL and PL Cage?
The AccuLIF TL and PL Cage is available in specific sizes tailored for lumbar interbody applications. These sizes are designed to accommodate the anatomical variations of the lumbar spine, ensuring proper fit and function during spinal fusion procedures. Exact dimensions should be referenced in the manufacturer’s product documentation.
How should the AccuLIF TL and PL Cage be stored to maintain sterility and functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping it in its original, sealed packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the hydraulic system remains intact and the titanium cage retains its structural integrity for surgical use.