510(k) · Cleared
ClearedArtisan Space Maintenance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · JEY Plate, Bone
Cleared on May 30, 2012 as substantially equivalent to K100779 (Medtronic Sofamor Danek USA, Inc., 2010) and 1 other predicate after a 121-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- May 30, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894844 (1990). 33 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK071585 P.004 Healing Abutments and Closure ScrewsStraumann USA · 2007 · Recalled
- 2 generations backK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 1 generation backK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK120271 Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 7 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 6 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 5 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 4 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 3 generations backK071585 P.004 Healing Abutments and Closure ScrewsStraumann USA · 2007 · Recalled
- 2 generations backK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 1 generation backK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK120271 Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −7 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −6 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −5 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −4 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −3 | K071585 | P.004 Healing Abutments and Closure Screws | Straumann USA | 2007 | 1 |
| −2 | K100779 | Sustain Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −1 | K110259 | Architex Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| 0 (this device) | K120271 | Artisan Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 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? (2)
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 |
|---|---|---|---|
| * | K100779 | Sustain Space Maintenance SystemSummary page 1…872.4760) Product Code: JEY, DZE III. Predicate Devices ARCHITEX TM Space Maintenance System (K1 00779 SE 12/13/2010, and K1 10259 SE 04/13/2011) IV. Device Description The ARTISAN"n… | 2010 |
| * | K110259 | Architex Space Maintenance SystemSummary page 1…Product Code: JEY, DZE III. Predicate Devices ARCHITEX TM Space Maintenance System (K1 00779 SE 12/13/2010, and K1 10259 SE 04/13/2011) IV. Device Description The ARTISAN"n Space Maintenance System is a comprehensive,… | 2011 |
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 22 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 33 ancestors have a recall of any class.
- 1 other device also cites its predicate K100779.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The ARTISANTM Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or titanium mesh in bony defects of oral maxillofacial anatomy.
The ARTISANTM Space Maintenance System is intended for temporary use in oral maxillofacial surgical reconstruction and dental regeneration procedures for maintaining space during bone grafting procedures and to support soft tissue until bone formation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120271: Artisan Space Maintenance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120271
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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