Alliance Glenoid
by Zimmer, Inc.
510(k) K191814
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191814 | Date23 Oct 2019 | 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- Withdrawn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
- KWS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Alliance Glenoid is an anatomic glenoid replacement system designed for shoulder arthroplasty. It provides both standard and augmented implant options, including a half-wedge design, to address posterior glenoid erosion while preserving bone structure. The modular 4-peg system ensures secure fixation and alignment during implantation.
This device is intended for use in orthopedic surgical settings and is supplied sterile for single-use. The half-wedge augment targets subchondral bone defects, offering versatility in addressing varying degrees of posterior erosion. Authorized under FDA 510(k) clearance (K191814), it adheres to traditional review standards and is classified under the Orthopedic advisory committee’s product code KWS.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Alliance Glenoid used for in shoulder surgery?
The Alliance Glenoid is designed specifically for anatomic glenoid replacement during shoulder arthroplasty. It addresses posterior glenoid erosion by providing standard and augmented implant options, including a half-wedge design, to preserve bone structure while ensuring secure fixation via a modular 4-peg system. This modularity allows surgeons to tailor the implant to the patient’s unique bone anatomy and erosion patterns.
How is the Alliance Glenoid supplied, and is it reusable?
The Alliance Glenoid is supplied sterile and intended for single-use only. This ensures patient safety by minimizing the risk of infection and contamination, which is critical in orthopedic procedures where sterility is paramount. Single-use also aligns with best practices for reducing cross-contamination in surgical settings.
What types of glenoid defects does the half-wedge augment target?
The half-wedge augment in the Alliance Glenoid system is engineered to target subchondral bone defects, particularly those caused by posterior glenoid erosion. This feature provides versatility, allowing surgeons to address varying degrees of erosion while maintaining structural integrity. The augment helps restore the glenoid surface without extensive bone resection, preserving as much native bone as possible.
Are there different sizes or models available for the Alliance Glenoid?
Yes, the Alliance Glenoid system includes both standard and augmented implant options, with the half-wedge augment being a key distinguishing feature. While the exact sizing details are not specified in the provided data, the modular 4-peg design suggests multiple configurations to accommodate different patient anatomies. Surgeons can select the appropriate size and model based on preoperative imaging and intraoperative assessment of the glenoid defect.
How should the Alliance Glenoid be stored before use?
Since the Alliance Glenoid is sterile and single-use, it should be stored in its original packaging in a clean, dry environment protected from moisture, dust, and direct sunlight. The packaging should remain intact until immediately before use to maintain sterility. Proper storage ensures the device remains uncontaminated and functional until the time of surgery.