510(k) · Cleared
ClearedMacropore Hydrosorb Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 28, 2004 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) and 3 other predicates after an 89-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K010911 (2001). 4 ancestors in all, the oldest K002063 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 1 generation backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- This deviceK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK051821 Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK071810 Inion Spinal Graft Containment SystemInion, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK151360 Inion Spinal Graft Containment SystemInion OY · 2015
- Descendant · cites it directly · 0 of its ownK063461 Anova Containment DeviceAnova Corporation · 2009
Most influential descendants
Showing 4 of 4 · See all- K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005 · cites it directly2descendants
- K071810Inion Spinal Graft Containment SystemInion, Ltd. · 2008 · cites it directly1descendant
- K151360Inion Spinal Graft Containment SystemInion OY · 2015 · 2 generations on0descendants
- K063461Anova Containment DeviceAnova Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −1 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| 0 (this device) | K041105 | Macropore Hydrosorb Spine System | Macropore Biosurgery, Inc. | 2004 | — |
| +1 | K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion System | Inion, Ltd. | 2005 | — |
| +1 | K071810 | Inion Spinal Graft Containment System | Inion, Ltd. | 2008 | — |
| +2 | K151360 | Inion Spinal Graft Containment System | Inion OY | 2015 | — |
| +1 | K063461 | Anova Containment Device | Anova Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K010911 | Macropore OS Spinal SystemSummary page 3…principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: MacroPore OS Spinal System (K010911), the DePuy AcroMed BowTi Anterior Buttress Staple System (K021039), Exactech Teeres Cemex (K000943), and the Bryan Biotrace Mo… | 2001 |
| * | K021039 | Bowti Anterior Buttress Staple SystemSummary page 3…termined by FDA to be substantially equivalent to pre-amendment devices: MacroPore OS Spinal System (K010911), the DePuy AcroMed BowTi Anterior Buttress Staple System (K021039), Exactech Teeres Cemex (K000943), and the Bryan Biotrace Model 1730 (K002063); Class II medical devices that were cleared for… | 2002 |
| * | K000943 | Cemex System Gun Application VersionSummary page 3…ly equivalent to pre-amendment devices: MacroPore OS Spinal System (K010911), the DePuy AcroMed BowTi Anterior Buttress Staple System (K021039), Exactech Teeres Cemex (K000943), and the Bryan Biotrace Model 1730 (K002063); Class II medical devices that were cleared for marketing in the United States.… | 2001 |
| * | K002063 | Biotrace, Model 1730Summary page 3…Pore OS Spinal System (K010911), the DePuy AcroMed BowTi Anterior Buttress Staple System (K021039), Exactech Teeres Cemex (K000943), and the Bryan Biotrace Model 1730 (K002063); Class II medical devices that were cleared for marketing in the United States. Indications For Use The MacroPore Hydrosorb… | 2000 |
What descends from it? (4)
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 3 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051821 (Inion, Ltd., 2005) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K010911.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The MacroPore Hydrosorb Spine System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041105: Macropore Hydrosorb Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041105
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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