510(k) · Cleared
ClearedSmart SPACE Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techmah Medical, LLC · QHE Shoulder Arthroplasty Implantation System
Cleared on Feb 3, 2021 as substantially equivalent to K191247 (Techmah Medical, LLC, 2019) after a 184-day review. Its family tree reaches back 13 generations to 1991. 1 later device descends from it.
- Decided
- Feb 3, 2021
- Review
- 184 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K905070 (1991). 101 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
- This deviceK202151 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK222405 Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. · 2022
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 6 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 5 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 4 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
- This deviceK202151 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −6 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −5 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −4 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −2 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −1 | K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019 | — |
| 0 (this device) | K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191247 | SmartSPACE Shoulder SystemSummary page 5…S Predicate Manufacturer: TechMah Medical LLC Predicate Trade Name: SmartSPACE Shoulder System Predicate 510(k): K191247 Predicate Product Code: QHE, KWS, MBF Reference Manufacturer: Orthosoft Inc. (d/b/a Zimmer CAS)… | 2019 |
| † | K192080 | iASSIST Knee System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | 2022 | 0 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 101 ancestors have a recall of any class.
- Of its descendants, K222405 (Lima Corporate S.P.A., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K191247.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Smart SPACE Shoulder 3D Positioner Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Smart SPACE Shoulder Cubit Guidance Smart SPACE Shoulder Cubit Guidance…
Read the full statement (278 words)
Smart SPACE Shoulder 3D Positioner
Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Cubit Guidance
Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Planner software
Smart SPACE Shoulder Planner software 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 software runs on standard personal and business computers running Microsoft Windows operating system.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.
Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan.
The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
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/K202151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202151: Smart SPACE Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202151
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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