U2 Total Knee System E-XPE products— 510(k) K161705

Name: FDA 510(k) clearance K161705
Creator: U.S. Food and Drug Administration
Published: 2017-03-16

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K161705 for U2 Total Knee System E-XPE products, Substantially Equivalent on 2017-03-16. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant: United Orthopedic Corporation
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2016-06-20
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from United Orthopedic Corporation

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K253948 — Momentum Acetabular Cup System2026-09-02
K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)2025-09-25
K252303 — Stem Extension Line (USTAR II System)2025-08-22
K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella2025-07-31
K242315 — Resolve Modular Revision Hip Stem2025-05-01

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.