Avanti Orthopaedics, LLC · Class II · Cleared May 9, 2026
| K-number | K261145 |
| Device name | Avanti Distal Elbow ORIF System |
| Applicant | Avanti Orthopaedics, LLC |
| Product code | HRS |
| Device class | Class II |
| Decision date | May 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The Avanti Distal Elbow ORIF System is a plate and screw fixation system designed to treat fractures, osteotomies, malunions, and non-unions of the olecranon, radius, and ulna in adults. The system includes olecranon plates in 5 sizes, straight plates in 2 sizes, and curved plates in left and right configurations, all manufactured from 316LS stainless steel with some plates featuring PEEK inserts for variable-angle fixation.
The subject device plates share the same intended use, principle of operation, material (316LS stainless steel per ASTM F138 or F139), plate geometry, number of screw holes, compatible screw diameter, and compatible screw length as the predicate devices. Minor differences exist only in indications for use clarification and component geometry/size offerings, with no significant technological differences identified.
ASTM F138 and ASTM F139 for stainless steel material specification. The device is subject to ISO 13485 for quality management systems, including design controls (clause 7.3), nonconforming product handling (clause 8.3), corrective action (clause 8.5.2), and preventive action (clause 8.5.3).
View the full FDA submission: accessdata.fda.gov