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510(k) K110415

SIGNATURE PLANNER / SIGNATURE GUIDES by Materialise NV — Product Code HRY

K110415 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "SIGNATURE PLANNER / SIGNATURE GUIDES". The FDA issued a decision of Substantially Equivalent on May 16, 2011. 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. Materialise NV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2011
Date Received
February 14, 2011
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 Materialise NV

  • K260802 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (June 9, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF T (January 7, 2026)
  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (February 21, 2025)
  • K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (October 18, 2024)
  • K223427 — Mimics Enlight CMF (May 31, 2024)
  • K241143 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (May 22, 2024)
  • K233217 — Mimics Cardiac Planner (February 12, 2024)

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)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)
  • K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM (September 22, 2008)

FDA data resources