510(k) · Cleared
ClearedSmart SPACE Shoulder Planner and 3D Positioners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · QHE Shoulder Arthroplasty Implantation System
Cleared on Dec 20, 2022 as substantially equivalent to K202151 (Techmah Medical, LLC, 2021) and 2 other predicates after a 133-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Dec 20, 2022
- Review
- 133 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K905070 (1991). 103 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations between
- 3 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 2 generations backK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
- 1 generation backK202454 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2020
- This deviceK222405 Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. · 2022
Show all 14 generations
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 12 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 9 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 8 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 7 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 6 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 5 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 4 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 3 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 2 generations backK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
- 1 generation backK202454 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2020
- This deviceK222405 Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −13 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −12 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −9 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −8 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −7 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −6 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −5 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −4 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −2 | K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019 | — |
| −1 | K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020 | — |
| 0 (this device) | K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2021 | 1 | 0 |
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 K242813 Materialise Shoulder System™, Materialise…score 19.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202151 | Smart SPACE Shoulder SystemSummary page 5…select surgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454, K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positi… | 2021 |
| * | K202454 | Smart SPACE Shoulder SystemSummary page 5…rgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454, K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and… | 2020 |
| * | K191247 | SmartSPACE Shoulder SystemSummary page 5…ecution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454, K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anat… | 2019 |
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 31 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 19 of the 103 ancestors have a recall of any class.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QHE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHE
181in 2025
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
MAUDE reports naming product code QHE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 88 | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 149 | 0 | 0 |
| 2023 | 6 | 103 | 0 | 0 |
| 2024 | 4 | 97 | 0 | 5 |
| 2025 | 3 | 181 | 0 | 1 |
| 2026 | 4 | 59 | 0 | — |
What is it indicated for?
The Smart SPACE Shoulder 3D Positioners and Smart SPACE Shoulder Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to be a surgical tool to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans. The Smart SPACE Shoulder 3D Positioners are intended, by guiding the surgical…
Read the full statement (302 words)
The Smart SPACE Shoulder 3D Positioners and Smart SPACE Shoulder Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to be a surgical tool to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans.
The Smart SPACE Shoulder 3D Positioners are intended, by guiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.
The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioners is properly placed on the anatomical compartment.
These devices must be exclusively utilized by an orthopaedic surgeon who has a good knowledge of the specific operative technique.
Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.
Smart SPACE Shoulder Planner
Smart SPACE Shoulder Planner is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner is to be used for adult patients only and should not be used for diagnostic purposes.
Smart SPACE Shoulder Planner is intended to be used for adult patients planning only.
The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty.
The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222405: Smart SPACE Shoulder Planner and 3D Positioners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222405
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026