510(k) · Cleared
ClearedSpace 360 Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dfine, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jun 29, 2007 as substantially equivalent to K040483 (Medtronic Sofamor Danek, Inc., 2004) and 2 other predicates after a 143-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Jun 29, 2007
- Review
- 143 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K002652 (2001). 20 ancestors in all, the oldest K000778 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 6 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 5 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 3 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- 2 generations backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
- 1 generation backK063067 Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd. · 2006
- This deviceK070351 Space 360 Delivery SystemDfine, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK090986 Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation…Dfine, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −6 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −5 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −3 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| −2 | K062424 | Confidence EX High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| −1 | K063067 | Confidence Fenestrated Introducer Needle | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| 0 (this device) | K070351 | Space 360 Delivery System | Dfine, Inc. | 2007 | — |
| +1 | K090986 | Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System… | Dfine, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K040483 | Equestra Fluid Delivery SystemSummary page 1…ent, Cement Dispenser 3. Predicate Device: The SPACE 360 Delivery System is substantially equivalent to the Equestra, cleared under 510(k) K040483 by Medtronic Sofamor Danek, the Confidence Fenestrated Introducer Needle cleared under 510(k) K063067by Disc-C-Tech, the D… | 2004 |
| * | K063067 | Confidence Fenestrated Introducer NeedleSummary page 1…ally equivalent to the Equestra, cleared under 510(k) K040483 by Medtronic Sofamor Danek, the Confidence Fenestrated Introducer Needle cleared under 510(k) K063067by Disc-C-Tech, the Disc-C-Tech Cementer Injector classified under Product Code KIH and the ArthroCare System, clear… | 2006 |
| * | K040338 | Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Summary page 1…red under 510(k) K063067by Disc-C-Tech, the Disc-C-Tech Cementer Injector classified under Product Code KIH and the ArthroCare System, cleared under 510(k) K040338 by ArthoCare. 4. Intended use of the device The SPACE 360 Delivery System is intended for percutaneous… | 2004 |
| * | — | Disc-C-Tech Cementer Injector Named without a submission number |
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 |
|---|---|---|---|
| K090986 | Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/… | 2009 | 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 6 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K090986 (Dfine, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K040483.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070351: Space 360 Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070351
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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