Evidence-Based Innovation. Clinical Confidence.
In today’s orthopaedic landscape, excellence is defined by evidence-based performance and long-term outcomes. Within this framework, ODEP ratings and the Beyond Compliance program serve as the most authoritative benchmarks for evaluating implant durability, safety, and surgical success.
The Orthopaedic Data Evaluation Panel (ODEP) provides independent validation of implant survivorship, ensuring that every system meets the highest standards of clinical evidence.
PRIMA Shoulder System: A New Milestone in Clinical Validation
We are proud to announce that the PRIMA Shoulder System has reached a significant milestone: the PRIMA stem and PRIMA TT glenoid have officially achieved the ODEP PreEntry A* rating.
This achievement is underpinned by our participation in Beyond Compliance, a rigorous service designed to support the phased introduction of new medical devices. Through real-time monitoring and the oversight of an independent Advisory Group—comprised of the most respected experts in the field—we ensure that the PRIMA system's performance is scrutinized at every stage.
Prima TT glenoid
Prima Stem
Clinical Performance & Surveillance Highlights:
- Active Monitoring: 13 sites are currently active within the Beyond Compliance program, providing high-quality data on patient recovery and implant stability.
- Implant Volume: 144 PRIMA TT glenoids (18 centers) and 90 PRIMA stems (14 centers), with approximately 20% utilized in anatomic procedures.
- Proven Safety: Only two revisions have been reported to date, reinforcing the system’s reliability during this critical introductory phase.
Engineering Trust through Data
The data collected through Beyond Compliance is made available to clinicians and independent assessors in real-time. This transparency is essential for securing future long-term ODEP ratings for both anatomic and reverse constructs.
With the PRIMA system, your surgical choice is backed by a partnership between industry-leading engineering and the highest level of independent clinical scrutiny. We remain dedicated to providing the evidence you need to deliver the best possible care for your patients.
Discover all Enovis ODEP ratings and clinical data at: https://www.odep.org.uk/