510(k) · Cleared
ClearedSky Bone Expander System (Sky System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disc-O-Tech Medical Technologies, Ltd. · HRX Arthroscope
Cleared on Jun 17, 2004 as substantially equivalent to K032358 (Disc-O-Tech Medical Technologies, Ltd., 2003) and 1 other predicate after a 101-day review. Its family tree reaches back 7 generations to 1997. 13 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 101 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K970097 (1997). 29 ancestors in all, the oldest K803106 (1981). 13 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 5 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 4 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 3 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 2 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 1 generation backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- This deviceK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- Descendant · cites it directly · 12 of its ownK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- Descendant · 2 generations on · 11 of its ownK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- Descendant · 3 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · 4 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
- Descendant · 5 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K053336Staxx FX SystemSpine Wave, Inc. · 2006 · cites it directly12descendants
- K063606Modification to Staxx FX SystemSpine Wave, Inc. · 2007 · 2 generations on11descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 3 generations on9descendants
- K181262SpineJack Expansion KitVexim SA · 2018 · 4 generations on4descendants
- K202393SpineJack Expansion KitStryker Corporation · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −6 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −5 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −4 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −3 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −2 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −1 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| 0 (this device) | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| +1 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| +2 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| +3 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +4 | K181262 | SpineJack Expansion Kit | Vexim SA | 2018 | — |
| +5 | K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K032358 | B-Twin Bone Expander System (B-Twin BE System)Summary page 2…prietary Name SKy Bone Expander System (SKy System) Classification Class IT G74731001t -15201 ~1 ~~WI. Predicate Devices , B-Twin BE System (K032358) by Disc-O-Tecb Medical Technologies, Ltd. , SKy Bone Expander System (K034037) by Disc-Q-Tech Medical Technologies,… | 2003 |
| * | K034037 | Sky Bone Expander SystemSummary page 2…G74731001t -15201 ~1 ~~WI. Predicate Devices , B-Twin BE System (K032358) by Disc-O-Tecb Medical Technologies, Ltd. , SKy Bone Expander System (K034037) by Disc-Q-Tech Medical Technologies, Ltd. Intended Use The SKy Bone Expander System is intended for use as a convention… | 2004 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053336 | Staxx FX System | 2006 | 12 |
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 7 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 6 of the 29 ancestors have a recall of any class.
- Of its descendants, K053336 (Spine Wave, Inc., 2006) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K032358.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancelious bone in the spine, hand, tibia, radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cements that are legally marketed for use in vertebroplasty or kyphoplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040612: Sky Bone Expander System (Sky System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040612
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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