Neo Total Knee System— 510(k) K142388

Name: FDA 510(k) clearance K142388
Creator: U.S. Food and Drug Administration
Published: 2014-12-05

Substantially Equivalent

New Era Orthopedics, LLC

FDA 510(k) clearance K142388 for Neo Total Knee System, Substantially Equivalent on 2014-12-05. Applicant: New Era Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: New Era Orthopedics, LLC
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2014-08-27
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hummelstown, PA, US

Download summary PDF View on FDA.gov ↗

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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

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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.