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510(k) K100973

EVOLUTION UNICONDYLAR KNEE SYSTEM by Wrightmedicaltechnologyinc — Product Code HRY

K100973 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "EVOLUTION UNICONDYLAR KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 10, 2010. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2010
Date Received
April 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

Other clearances by Wrightmedicaltechnologyinc

  • K222835 — Prophecy Preoperative Navigation Alignment System (January 27, 2023)
  • K213342 — PRO-DENSE LoVisc Bone Graft Substitute (January 5, 2022)
  • K212996 — Sterile PHALINX Hammertoe System (November 16, 2021)
  • K202815 — PROPHECY Preoperative Navigation Alignment System (March 10, 2021)
  • K201259 — ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (January 8, 2021)
  • K200507 — PRO-DENSE LoVisc Bone Graft Substitute (October 21, 2020)
  • K193067 — The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISIO (June 8, 2020)
  • K191393 — INFINITY Total Ankle System, INBONE Total Ankle System (August 22, 2019)
  • K190970 — PROSTEP™ TBI™ (Tailors Bunion Implant) System (August 13, 2019)
  • K183620 — PROSTEP TBC Implant System (June 6, 2019)

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)
  • K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM (September 22, 2008)

FDA data resources