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510(k) K191779

Attune Revision LPS Inserts by Depuy(Ireland) — Product Code KRO

K191779 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "Attune Revision LPS Inserts". The FDA issued a decision of Substantially Equivalent on October 8, 2019. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Depuy(Ireland) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2019
Date Received
July 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Depuy(Ireland)

  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K192855 — DELTA XTEND(TM) Reverse Shoulder System (February 24, 2020)
  • K190344 — DePuy Corail AMT Hip Prosthesis (November 1, 2019)
  • K192448 — Delta Xtend Revers Shoulder System (October 4, 2019)
  • K183077 — Delta Xtend Reverse Shoulder System (May 17, 2019)
  • K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing (June 15, 2017)
  • K160907 — DePuy Actis DuoFix Hip Prosthesis (July 19, 2016)
  • K160700 — ATTUNE Revision Knee System (June 10, 2016)
  • K140881 — DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (February 13, 2015)
  • K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM (April 3, 2014)

Other clearances for product code KRO

  • K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (August 6, 2026)
  • K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell (December 15, 2025)
  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S (March 21, 2024)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (May 19, 2023)
  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)

FDA data resources