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FDA 510(k)

Klassic Infection Spacer System

K-Number: K261734 · 2026-07-23

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2026-07-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Infection Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261734. 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 Klassic Infection Spacer System?

Klassic Infection Spacer System is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K261734.

When did Klassic Infection Spacer System receive FDA 510(k) clearance?

Klassic Infection Spacer System received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261734.

Who is the listed applicant for Klassic Infection Spacer System?

The FDA 510(k) record lists Total Joint Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic Infection Spacer System?

The FDA product code for Klassic Infection Spacer System is JWH.

Other records listing Total Joint Orthopedics, Inc. as applicant

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.

K220483Platform® Acetabular SystemK211877Klassic Knee SystemK211602Klassic Knee SystemK202740Klassic Knee System Tibial Inserts, PS-MaxK183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link PolyK190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

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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.

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NVK252974EMPOWR KneeEncore Medical L.P.K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UCK253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.

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.

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