SIGNATURE PLANNER / SIGNATURE GUIDES— 510(k) K110415

Clearance details

Applicant

Materialise NV

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

2011-02-14

Decision date

2011-05-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Leuven, BE

• K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
• K190633 — NanoOrtho NanoKnee® System2019-12-20
• K152631 — MPO Total Knee Systems MR Labeling2016-03-23
• K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
• K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

• K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner2026-06-09
• K251964 — Mimics Thoracic Planner2026-03-12
• K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models2026-01-07
• K253793 — Materialise TKA Guide System2026-01-06
• K251554 — Materialise TKA Guide System2025-07-14

Injury

1,551

Malfunction

2,753

Total

4,304

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0628-2014 — REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.Class II·Terminated·Materialise USA LLC·20131126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110415.