RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS— 510(k) K051479

Name: FDA 510(k) clearance K051479
Creator: U.S. Food and Drug Administration
Published: 2005-08-10

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K051479 for RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS, Substantially Equivalent on 2005-08-10. Applicant: Biomet Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2005-06-03
Decision date: 2005-08-10
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 Biomet Manufacturing, Inc.

view all

K130390 — COMPREHENSIVE CONVERTIBLE GLENOID2013-10-09
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113121 — COMPREHENSIVE REVERSE SHOULDER2011-12-16
K080685 — HIPLOC COMPRESSION HIP SCREW2008-08-15
K080088 — BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS2008-06-11

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.