HINGED KNEE— 510(k) K982160

Name: FDA 510(k) clearance K982160
Creator: U.S. Food and Drug Administration
Published: 1999-03-17

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K982160 for HINGED KNEE, Substantially Equivalent on 1999-03-17. Applicant: Encore Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 1998-06-19
Decision date: 1999-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, 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 Encore Orthopedics, Inc.

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K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT2004-07-06
K020114 — 3D KNEE2002-07-12
K020741 — UNICONDYLAR KNEE2002-06-04
K020236 — MODIFICATION TO PASS SPINAL SYSTEM2002-02-14
K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP2002-02-11

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.