510(k) K252887

DePuy ATTUNE Knee System by DePuy Orthopaedics, Inc. — Product Code OIY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 22, 2026
Date Received: September 10, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device Class: Class II
Regulation Number: 888.3560
Review Panel: OR
Submission Type

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Other clearances by DePuy Orthopaedics, Inc.

K231503 — CUPTIMIZE Advanced (August 22, 2023)
K213839 — DePuy Corail AMT Hip Prosthesis (January 6, 2022)
K210167 — DELTA XTEND Reverse Shoulder System (February 19, 2021)
K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
K201347 — DePuy ATTUNE Total Knee System (June 18, 2020)
K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
K193398 — Summit DuoFix HA Coating (February 4, 2020)
K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)

Other clearances for product code OIY

K242665 — DePuy ATTUNE Total Knee System (November 1, 2024)
K201347 — DePuy ATTUNE Total Knee System (June 18, 2020)
K120038 — A200 KNEE SYSTEM (February 14, 2013)
K121727 — MOVATION KNEE SYSTEM (August 15, 2012)
K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELL (March 14, 2012)
K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM (August 30, 2011)
K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM (March 15, 2011)
K103223 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (December 21, 2010)
K101433 — DEPUY ATTUNE KNEE SYSTEM (December 10, 2010)
K091956 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (September 28, 2010)