Balanced Knee System TriMax Porous Femoral Components— 510(k) K253161

Name: FDA 510(k) clearance K253161
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K253161 for Balanced Knee System TriMax Porous Femoral Components, Substantially Equivalent on 2025-12-19. Applicant: Ortho Development Corp.. Device class: 2.

Clearance details

Applicant: Ortho Development Corp.
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2025-09-26
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBH

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K261462 — LANDMARK Total Knee System2026-09-08
K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

More clearances from Ortho Development Corp.

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K251052 — Trivicta® Hip Stem2025-05-22
K242984 — BKS Revision System2024-10-25
K242833 — Legend® Acetabular Shell2024-10-11
K233758 — Trivicta Hip Stem2024-03-08
K142146 — IBIS PEDICLE SCREW SYSTEM2014-12-11

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.