RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE— 510(k) K023667

Name: FDA 510(k) clearance K023667
Creator: U.S. Food and Drug Administration
Published: 2002-12-24

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K023667 for RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE, Substantially Equivalent on 2002-12-24. Applicant: Plus Orthopedics. Device class: 2.

Clearance details

Applicant: Plus Orthopedics
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2002-10-31
Decision date: 2002-12-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

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K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K251665 — Triathlon® Hinge Knee System2025-07-25
K242871 — ATTUNE Revision Hinge Knee2024-11-21

More clearances from Plus Orthopedics

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K032126 — PROMOS SHOULDER2004-01-08
K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM2003-12-18
K032709 — MODULAR PLUS HIP STEM2003-09-23
K032548 — IP-XS COMPRESSION NAIL SYSTEM2003-09-10
K032215 — VKS/TC-PLUS REVISION KNEE2003-08-08

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.