I.T.S. PRS Phoenix II— 510(k) K260054
Substantially EquivalentI.T.S. GmbH
FDA 510(k) clearance K260054 for I.T.S. PRS Phoenix II, Substantially Equivalent on 2026-04-24. Applicant: I.T.S. GmbH. Device class: 2.
Summary
I.T.S. GmbH's I.T.S. PRS Phoenix II is filed under product code HRS (Plate, Fixation, Bone). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 888.3030. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
I.T.S. filed from Laßnitzhöhe, Austria. Review took 106 calendar days (January 8 to April 24, 2026).
Clearance details
- Applicant
- I.T.S. GmbH
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laßnitzhöhe, AT
Recent devices under product code HRS
view allMore clearances from I.T.S. GmbH
view all- K260958 — I.T.S. Clavicle Plates with Angular Stability +11 more
- K233134 — I.T.S. INS Proximal Femur Nail
- K210935 — I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
- K142418 — I.T.S. Hand Locking Plates System - HLS
- K132945 — CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.