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.

Clearance details

Applicant: NovoSource
Product code: 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

K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K253793 — Materialise TKA Guide System2026-01-06

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.