FDA 510(k)

NovoKnee (SteriKnee)

K-Number: K261032 · 2026-04-27

Decision Date2026-04-27

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NovoKnee (SteriKnee) is the device name listed in this FDA 510(k) record. The listed applicant is NovoSource. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K261032. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoKnee (SteriKnee)?

NovoKnee (SteriKnee) is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is NovoSource. The 510(k) number is K261032.

When did NovoKnee (SteriKnee) receive FDA 510(k) clearance?

NovoKnee (SteriKnee) received FDA 510(k) clearance on 2026-04-27, under 510(k) number K261032.

Who is the listed applicant for NovoKnee (SteriKnee)?

The FDA 510(k) record lists NovoSource as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovoKnee (SteriKnee)?

The FDA product code for NovoKnee (SteriKnee) is JWH.

Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC K253793Materialise TKA Guide SystemMaterialise NV K252974EMPOWR KneeEncore Medical L.P.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.