| K-number | K260054 |
| Device name | I.T.S. PRS Phoenix II |
| Applicant | I.T.S. GmbH |
| Product code | HRS |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The I.T.S. PRS Phoenix II is a metallic bone fixation system consisting of various anatomically shaped plates and screws made of titanium. It is indicated to stabilize one or more pelvic bone fractures in adult patients, including symphyseal disruptions, sacroiliac joint disruptions, acetabular fractures, and posterior pelvic ring fractures, but is not intended for spinal use.
The device uses the same material as the predicate—titanium per ASTM F67 and ASTM F136, Type II anodized—with anatomically shaped plates and similar design characteristics. It includes multiple plate geometries (symphysis, W-plates, anterior/posterior column plates, biplanar plates) and various screw types (cortical, cancellous, locking, non-locking) in diameters ranging from 2.7 mm to 5.9 mm.
FEA simulation per ASTM F382; screw testing per ASTM F543; bioburden and sterility per ISO 11137-1, 11137-2, 11137-3; endotoxin per Ph. Eur. 2.6.14/USP <85>; cytotoxicity per ISO 10993-5; RF-heating per ASTM F2182-19e2; magnetic force per ASTM F2052-21; magnetic torque per ASTM F2213-17; image artifact per ASTM F2119-24.
The I.T.S. PRS Phoenix II is substantially equivalent to its predicate devices because it shares the same material composition, anatomical plate designs, and operational principles. Engineering analysis and performance testing demonstrated mechanical equivalence to the primary predicate (I.T.S. PRS RX & PRS Phoenix, K210935), with all worst-case products meeting or exceeding the performance criteria of cleared devices.
View the full FDA submission: accessdata.fda.gov