510(k) · Cleared
ClearedOstapek VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Ligne AG · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 24, 2008 as substantially equivalent to K052384 (Lanx, LLC, 2005) and 2 other predicates after a 309-day review. Its family tree reaches back 8 generations to 1984. 1 later device descends from it.
- Decided
- Jun 24, 2008
- Review
- 309 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 4 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 2 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- This deviceK072326 Ostapek VBR SystemCo-Ligne AG · 2008
- Descendant · cites it directly · 0 of its ownK173893 TrabisColigne AG · 2018
Most influential descendants
Showing 1 of 1 · See all- K173893TrabisColigne AG · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −4 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −2 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K072326 | Ostapek VBR System | Co-Ligne AG | 2008 | — |
| +1 | K173893 | Trabis | Coligne AG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K052384 | Lanx VBR SystemSummary page 1…. EquivalentPredicateDevice: coLigne AG. believes that the OstaPek®VBR is substantially equivalent to the VBR systems identified below: K052384 - Lanx VBR, Lanx, LLC K052746 - Concord VBR, DePuy Spine, Inc. K032064 - Theken LPOD, VBR, Theken, Surgical… | 2005 |
| * | K052746 | Concorde VBR Spinal SystemSummary page 1…coLigne AG. believes that the OstaPek®VBR is substantially equivalent to the VBR systems identified below: K052384 - Lanx VBR, Lanx, LLC K052746 - Concord VBR, DePuy Spine, Inc. K032064 - Theken LPOD, VBR, Theken, Surgical Equivalence can be seen in the des… | 2005 |
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 1…is substantially equivalent to the VBR systems identified below: K052384 - Lanx VBR, Lanx, LLC K052746 - Concord VBR, DePuy Spine, Inc. K032064 - Theken LPOD, VBR, Theken, Surgical Equivalence can be seen in the design, material composition, surgical technique and… | 2004 |
| † | K051089 | Gii Spinal Fixation System | 2005 |
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 |
|---|---|---|---|
| K173893 | Trabis | 2018 | 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 24 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K173893 (Coligne AG, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052384.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The OstaPek® VBR System are vertebral body (partial or total) replacement devices intended for use in the thoracolumbar spine (T1 - L5) to replace and restore height to a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (fracture or disease). The system is to be used in association with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended is the coLigne, AG, GIISpinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072326 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072326: Ostapek VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072326
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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