Consensus Knee System with TiNbN— 510(k) K241180

Name: FDA 510(k) clearance K241180
Creator: U.S. Food and Drug Administration
Published: 2025-01-14

Substantially Equivalent

Shalby Advanced Technologies

FDA 510(k) clearance K241180 for Consensus Knee System with TiNbN, Substantially Equivalent on 2025-01-14. Applicant: Shalby Advanced Technologies. Device class: 2.

Clearance details

Applicant: Shalby Advanced Technologies
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2024-04-29
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K262057 — GMK Extension2026-09-15
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

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.