Simpliciti Shoulder System
510(k) K143552
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143552 | Date4 Mar 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- Withdrawn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
- PKC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Simpliciti Shoulder System is a canal-sparing total anatomic shoulder prosthesis designed for uncemented metaphyseal humeral stem fixation without diaphyseal incursion. It is classified as a semi-constrained total shoulder arthroplasty, intended for anatomical restoration of the shoulder joint while avoiding humeral canal variables.
This device is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K143552) as substantially equivalent to existing shoulder prostheses. It is used in orthopedic settings for patients with degenerative joint conditions, excluding cases of insufficient bone support, skeletal immaturity, osteoporosis, erosive arthritis, metal allergies, or active infection. Multiple FEI and registration numbers (e.g., 1000306303, 3000258338) correspond to its various component configurations.
Other devices from Tornier, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of shoulder conditions is the Simpliciti Shoulder System designed to address in patients?
The Simpliciti Shoulder System is specifically designed for patients with degenerative joint conditions affecting the shoulder, such as osteoarthritis or other degenerative arthritis. It is not intended for cases involving insufficient bone support, skeletal immaturity, osteoporosis, erosive arthritis, metal allergies, or active infection. The system focuses on anatomical restoration of the shoulder joint while preserving the humeral canal.
How is the Simpliciti Shoulder System supplied, and is it reusable?
The Simpliciti Shoulder System is supplied as a sterile, single-use orthopedic implant. This means each component is intended for one surgical procedure only and should not be reused, ensuring patient safety and sterility.
What regulatory pathway was followed for the FDA clearance of the Simpliciti Shoulder System?
The Simpliciti Shoulder System received FDA clearance through a 510(k) pathway, specifically under the traditional review process. It was determined to be substantially equivalent to existing shoulder prostheses, as indicated by the clearance number K143552. This classification falls under the Orthopedic specialty and Prosthesis category for total anatomic shoulder replacements.
Does the Simpliciti Shoulder System come in multiple sizes or configurations, and how are they identified?
Yes, the Simpliciti Shoulder System includes multiple configurations to accommodate different anatomical needs. These are identified by various FEI (Final Establishment Identification) numbers and registration numbers, such as 1000306303, 3000258338, and others listed in the specifications. These numbers correspond to distinct component sets designed for specific surgical applications.
What storage requirements or handling instructions should be followed for the Simpliciti Shoulder System?
While specific storage instructions are not detailed in the provided data, the system is supplied as sterile and single-use. It should be stored in a clean, dry environment, protected from contamination, and handled using aseptic techniques to maintain sterility until use. Always follow manufacturer-provided guidelines for unpacking and preparing the device for surgery.