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510(k) K252887

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

K252887 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DePuy ATTUNE™ Knee System". The FDA issued a decision of Substantially Equivalent on May 22, 2026. The device falls under product code OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive), a Class II device regulated under 21 CFR 888.3560. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)
  • K192919 — Pinnacle Duofix HA Acetabular Cup 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)

FDA data resources