Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Consensus Knee System with TiNbN

K-Number: K241180 · 2025-01-14

ApplicantShalby Advanced Technologies
Decision Date2025-01-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Consensus Knee System with TiNbN is the device name listed in this FDA 510(k) record. The listed applicant is Shalby Advanced Technologies. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241180. 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 Consensus Knee System with TiNbN?

Consensus Knee System with TiNbN is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Shalby Advanced Technologies. The 510(k) number is K241180.

When did Consensus Knee System with TiNbN receive FDA 510(k) clearance?

Consensus Knee System with TiNbN received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241180.

Who is the listed applicant for Consensus Knee System with TiNbN?

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

What is the FDA product code for Consensus Knee System with TiNbN?

The FDA product code for Consensus Knee System with TiNbN 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 UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

View on FDA Database →

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

↑