NovoKnee (SteriKnee)— 510(k) K261032

Name: FDA 510(k) clearance K261032
Creator: U.S. Food and Drug Administration
Published: 2026-04-27

Substantially Equivalent

NovoSource

FDA 510(k) clearance K261032 for NovoKnee (SteriKnee), Substantially Equivalent on 2026-04-27. Applicant: NovoSource. Device class: 2.

Summary

NovoSource's NovoKnee (SteriKnee) is filed under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). The record doesn't describe the knee beyond its name and that code name.

Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).

NovoSource filed from Morgantown, West Virginia. The record shows 28 calendar days from receipt to decision (March 30 to April 27, 2026).

Clearance details

Applicant: NovoSource
Product code: Product code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2026-03-30
Decision date: 2026-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Morgantown, WV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

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.