510(k) · Cleared
ClearedArchitex 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 Apr 13, 2011 as substantially equivalent to K080074 (Ace Surgical Supply Co., Inc., 2008) and 1 other predicate after a 75-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Apr 13, 2011
- Review
- 75 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894844 (1990). 32 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 6 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 5 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 4 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 3 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 2 generations backK071585 P.004 Healing Abutments and Closure ScrewsStraumann USA · 2007 · Recalled
- 1 generation backK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
- This deviceK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK120271 Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −6 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −5 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −4 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −3 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −2 | K071585 | P.004 Healing Abutments and Closure Screws | Straumann USA | 2007 | 1 |
| −1 | K100779 | Sustain Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| 0 (this device) | K110259 | Architex Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XXSummary page 2…equivalence Hex Self Drilling ACE Tru Scrw' Geometrically, crews (1(080074) materially, and mechanically… | 2008 |
| * | K100779 | Sustain Space Maintenance SystemSummary page 2…cation is the dimensional modification to the diameter of the mesh fixation screws (Hex Self Drilling Screws) from the previously cleared implants in K100779. The device description in the IFU was also amended, which removed the implant sizes, the list of class I exempt placem… | 2010 |
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 |
|---|---|---|---|
| K120271 | Artisan Space Maintenance System | 2012 | 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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K120271 (Medtronic Sofamor Danek USA, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080074.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ARCHITEX 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110259: Architex 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/K110259
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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