EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS— 510(k) K111432

Name: FDA 510(k) clearance K111432
Creator: U.S. Food and Drug Administration
Published: 2011-08-19

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K111432 for EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS, Substantially Equivalent on 2011-08-19. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2011-05-23
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Wrightmedicaltechnologyinc

view all

K222835 — Prophecy Preoperative Navigation Alignment System2023-01-27
K213342 — PRO-DENSE LoVisc Bone Graft Substitute2022-01-05
K212996 — Sterile PHALINX Hammertoe System2021-11-16
K202815 — PROPHECY Preoperative Navigation Alignment System2021-03-10
K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System2021-01-08

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.