510(k) · Cleared
ClearedostaPek Interbody Fusion Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coligne AG · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 14, 2018 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 3 other predicates after a 114-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it.
- Decided
- Nov 14, 2018
- Review
- 114 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 76 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK181963 ostaPek Interbody Fusion CagesColigne AG · 2018
- Descendant · cites it directly · 0 of its ownK230478 Acro Composites Interbody SystemAcro Composites, LLC · 2023
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 4 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK181963 ostaPek Interbody Fusion CagesColigne AG · 2018
Most influential descendants
Showing 1 of 1 · See all- K230478Acro Composites Interbody SystemAcro Composites, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −4 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| 0 (this device) | K181963 | ostaPek Interbody Fusion Cages | Coligne AG | 2018 | — |
| +1 | K230478 | Acro Composites Interbody System | Acro Composites, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…ct Code MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Brantigan I/F Cage, DePuy Spine (P960025) Device Secondary Predicate Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140) Devices BAK… | 1999 |
| * | K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageSummary page 4…Orthopedic Primary Predicate Brantigan I/F Cage, DePuy Spine (P960025) Device Secondary Predicate Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140) Devices BAK Interbody Fusion System, Zimmer Spine (P950002) Ray Threaded Lumb… | 2011 |
| * | K151140 | LnK Lumbar Interbody Fusion Cage SystemSummary page 4…Orthopedic Primary Predicate Brantigan I/F Cage, DePuy Spine (P960025) Device Secondary Predicate Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140) Devices BAK Interbody Fusion System, Zimmer Spine (P950002) Ray Threaded Lumbar Fusio… | 2015 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 4…5) Device Secondary Predicate Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140) Devices BAK Interbody Fusion System, Zimmer Spine (P950002) Ray Threaded Lumbar Fusion Cage, Stryker (P950019) Reference Predicate Talos PLIF, MediTech (K090… | 1996 |
| † | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | 1996 |
| † | K090707 | Talos Intervertebral Body Fusion Device | 2009 |
| † | K173148 | ACIF | 2017 |
| † | K072326 | Ostapek VBR System | 2008 |
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 |
|---|---|---|---|
| K230478 | Acro Composites Interbody System | 2023 | 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 34 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 76 ancestors have a recall of any class.
- Of its descendants, K230478 (Acro Composites, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 98 other devices also cite its predicate P960025.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacrolumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the…
Read the full statement (150 words)
The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacrolumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181963: ostaPek Interbody Fusion Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181963
Report an extraction error
Are you the manufacturer?
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