510(k) · Cleared
ClearedAesculap Cespace XP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 15, 2013 as substantially equivalent to K083311 (Aesculap Implant Systems, Inc., 2009) after a 117-day review. Its family tree reaches back 12 generations to 2001. 7 later devices descend from it.
- Decided
- Apr 15, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003155 (2001). 40 ancestors in all, the oldest K841189 (1984). 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- This deviceK123909 Aesculap Cespace XPAesculap Implant System, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK161809 ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK171657 ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK221182 Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- This deviceK123909 Aesculap Cespace XPAesculap Implant System, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. · 2016 · cites it directly5descendants
- K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc. · 2017 · 2 generations on4descendants
- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · 3 generations on1descendant
- K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd. · 2022 · 3 generations on0descendants
- K221172FOCUS Interbody SystemOc Medical Devices · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −6 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −1 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| 0 (this device) | K123909 | Aesculap Cespace XP | Aesculap Implant System, Inc. | 2013 | — |
| +1 | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016 | — |
| +2 | K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017 | — |
| +3 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +3 | K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty), Ltd. | 2022 | — |
| +4 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | 2009 |
What descends from it? (7)
2 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 12 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 3 of the 40 ancestors have a recall of any class.
- Of its descendants, K161809 (Precision Spine, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K083311.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as a Vertebral Body Replacement Device: The Aesculap, PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (TI to L_5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended…
Read the full statement (243 words)
When used as a Vertebral Body Replacement Device:
The Aesculap, PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (TI to L_5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123909: Aesculap Cespace XP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123909
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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