510(k) · Cleared
ClearedSmartSPACE Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techmah Medical, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 15, 2019 as substantially equivalent to K162800 (Tornier S.A.S., 2017) after a 190-day review. Its family tree reaches back 12 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 15, 2019
- Review
- 190 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K905070 (1991). 100 ancestors in all, the oldest K800494 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations between
- 3 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 2 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 1 generation backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- This deviceK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
- Descendant · cites it directly · 1 of its ownK202151 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2021
- Descendant · cites it directly · 1 of its ownK202454 Smart SPACE Shoulder SystemTechmah Medical, LLC · 2020
- Descendant · cites it directly · 0 of its ownK222405 Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A. · 2022
Show all 12 generations
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 10 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 7 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 6 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 5 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 4 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 3 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 2 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 1 generation backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- This deviceK191247 SmartSPACE Shoulder SystemTechmah Medical, LLC · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −11 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −10 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −7 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −6 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −5 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −4 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −3 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −1 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| 0 (this device) | K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019 | — |
| +1 | K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021 | — |
| +1 | K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020 | — |
| +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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K162800 | BLUEPRINT Patient Specific InstrumentationSummary page 4…cate Manufacturer: Tornier SAS Predicate Trade Name: BLUEPRINT Patient Specific Instrumentation Predicate 510(k): K162800 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The SmartSPACE Shoulder System consists of th… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 100 ancestors have a recall of any class.
- Of its descendants, K202151 (Techmah Medical, LLC, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162800.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. SmartSPACE Shoulder Planner software SmartSPACE Shoulder Planner software is a…
Read the full statement (211 words)
SmartSPACE Shoulder 3D Positioner
SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
SmartSPACE Shoulder Planner software
SmartSPACE 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.
SmartSPACE 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 SmartSPACE Shoulder Planner software.
SmartSPACE 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.
SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191247: SmartSPACE Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191247
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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