510(k) Report

510(k) · Cleared

Cleared

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

K260802510(k) TraditionalCleared Jun 9, 202690-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Materialise NV · QHE Shoulder Arthroplasty Implantation System

Cleared on Jun 9, 2026 as substantially equivalent to K242813 (Materialise NV, 2024) after a 90-day review. Its family tree reaches back 8 generations to 2019.

Decided
Jun 9, 2026
Review
90 days
Class
Class II
Product code
QHE
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K190286 (2019). No later device cites it as a predicate yet.

Reference device: K241143 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2024Reference device: K233408 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023Reference device: K231112 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023Reference device: K230315 · Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner · Materialise NV · 2023Reference device: K220452 · Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner · Materialise NV · 2022Reference device: K212569 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2022Reference device: K193560 · Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner · Materialise NV · 2020Reference device: K190286 · Materialise Glenoid Positioning System · Materialise NV · 2019Reference device: K172054 · Materialise Glenoid Positioning System · Materialise NV · 2017Reference device: K170893 · Materialise Glenoid Positioning System · Materialise NV · 2017 · recalledReference device: K153602 · Materialise Glenoid Positioning System · Materialise NV · 2016 · recalledReference device: K131559 · Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides · Materialise NV · 2013K190286 · Materialise Glenoid Positioning System · Materialise NV · 2019K193560 · Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner · Materialise NV · 2020K212569 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2022K220452 · Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner · Materialise NV · 2022K231112 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023K233408 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023K241143 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2024K242813 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 20242016201820202022202420262028
K242813 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2024K241143 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2024K233408 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023K231112 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2023K220452 · Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner · Materialise NV · 2022K212569 · Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · 2022K193560 · Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner · Materialise NV · 2020K190286 · Materialise Glenoid Positioning System · Materialise NV · 2019−50
  1. Root · 8 generations backK190286 Materialise Glenoid Positioning SystemMaterialise NV · 2019
  2. 7 generations backK193560 Materialise Shoulder Guide and Models, Materialise SurgiCase…Materialise NV · 2020
  3. 6 generations backK212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2022
  4. 5 generations backK220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models…Materialise NV · 2022
  5. 4 generations backK231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2023
  6. 3 generations backK233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2023
  7. 2 generations backK241143 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2024
  8. 1 generation backK242813 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2024
  9. This deviceK260802 Materialise Shoulder System™, Materialise Shoulder Guide and Models…Materialise NV · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K190286Materialise Glenoid Positioning SystemMaterialise NV2019—
−7K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…Materialise NV2020—
−6K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2022—
−5K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase…Materialise NV2022—
−4K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2023—
−3K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2023—
−2K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2024—
−1K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2024—
0 (this device)K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase…Materialise NV2026—
FIG. 1 — Lineage of K260802, 2019–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QHE device

  1. #1 K242813 Materialise Shoulder System™, Materialise…score 19.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…
Summary page 7
…stem 510(k) Summary 510(k) Premarket Notification 510(k) number K242813 Decision date October 18, 2024…
Materialise NV2024—
†K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV2024—
†K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV2023—
†K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV2023—
†K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder…Materialise NV2023—
†K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…Materialise NV2022—
†K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV2022—
†K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…Materialise NV2020—
†K190286Materialise Glenoid Positioning SystemMaterialise NV2019—
†K172054Materialise Glenoid Positioning SystemMaterialise NV2017—
†K170893Materialise Glenoid Positioning SystemMaterialise NV20171
†K153602Materialise Glenoid Positioning SystemMaterialise NV20161
†K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV2013—

Also cleared against K242813: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 8 months on median.
  • None of the 8 ancestors has a recall.
  • 2 other devices also cite its predicate K242813.

How does its category compare?

All QHE devices

QHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · QHE

3in 2025

2019: 12020: 32021: 22022: 32023: 62024: 42025: 32026 (partial year): 4
2007high 6 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QHE

181in 2025

2020: 88 days median2022: 149 days median2023: 103 days median2024: 97 days median2025: 181 days median2026 (partial year): 59 days median
2007high 181 (2025) · low 88 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QHE

No recall names QHE since 2007.

Adverse event reports per year · QHE

1in 2025

2024: 52025: 1
2007high 5 (2024) · low 0 (2007)2025

MAUDE reports naming product code QHE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
202038800
20212—00
2022314900
2023610300
202449705
2025318101
20264590—

What is it indicated for?

Hardware The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with…

Read the full statement (343 words)

Hardware

The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Materialise Shoulder Guide and Models are single use only.

The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components:

- DePuy Synthes’

• GLOBAL® APG+ Shoulder System (K052472)

• DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694)

• GLOBAL® STEPTECH® APG Shoulder System (K092122)

• INHANCE™ Anatomic Shoulder System (K202716)¹

• INHANCE™ Reverse Shoulder System (K212737)

• INHANCE™ Hybrid Anatomic Glenoid Implant (K212933)

• INHANCE™ Reverse Glenoid Peripheral Posts (K221467)

• INHANCE Convertible Glenoid (K230831)

- Enovis’2 (DJO)

• Reverse® Shoulder Prosthesis (K051075, K092873, K112069)

• Turon® Shoulder System (K080402, K123982)

• AltiVate™ Anatomic Shoulder System (K162024)

• AltiVate™ Anatomic Augmented Glenoid (K213387, K222592)

• AltiVate™ Reverse Glenoid (K233481)

- Smith+Nephew’s3

• Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)

• Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999)

• AETOS Total Shoulder System (K220847, K230572)

• AETOS Reverse Shoulder System (K220847, K230572)

- Lima’s

• SMR™ Shoulder System (K100858)

• SMR™ Reverse Shoulder System (K110598)

• SMR™ Modular Glenoid (K113254) (K143256)

• SMR™ 3-Pegs Glenoid (K130642)

• SMR™ TT Metal Back Glenoid (K133349)

• SMR™ 40mm Glenosphere (K142139)

• SMR™ TT Augmented 360 Baseplate (K220792)

• SMR™ TT Hybrid Glenoid (K220792)

• PRIMA TT Glenoid (K222427, K252352)

Software

SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models.

Indications for use as stated in the FDA summary.

Also cleared against K242813

2 other devices cite the same predicate.

  • K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026
  • K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025

More from Materialise NV

62 FDA decisions under this applicant name. See the company

  • K260913CMF Titanium SplintsMaterialise NV · 2026
  • K251964Mimics Thoracic PlannerMaterialise NV · 2026
  • K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic…Materialise NV · 2026
  • K253793Materialise TKA Guide SystemMaterialise NV · 2026
  • K251554Materialise TKA Guide SystemMaterialise NV · 2025

Recent decisions in QHE

The QHE category page

  • K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
  • K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
  • K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026
  • K243509Archer PSI System3D-Side · 2025
  • K241470CORE Shoulder SystemLinkBio Corp. · 20251 recall

https://510kreport.com/device/K260802 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260802: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260802

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026