NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE— 510(k) K013385

Name: FDA 510(k) clearance K013385
Creator: U.S. Food and Drug Administration
Published: 2002-01-09

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K013385 for NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE, Substantially Equivalent on 2002-01-09. Applicant: Zimmer, Inc.. Device class: 2.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2001-10-12
Decision date: 2002-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

view all

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 Zimmer, Inc.

view all

K262955 — OsseoFit Stemless Shoulder System2026-09-24
K260831 — Z1 Hip System2026-06-16
K261683 — Augment Off-Axis Instrument System2026-06-16
K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27

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.