510(k) · Cleared
ClearedAesculap Cespace Peek Intervertebral Body Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 4, 2009 as substantially equivalent to K060762 (Aesculap, Inc., 2006) and 2 other predicates after a 114-day review. Its family tree reaches back 11 generations to 2001. 554 later devices descend from it.
- Decided
- Mar 4, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K003155 (2001). 39 ancestors in all, the oldest K841189 (1984). 554 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations between
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- Descendant · cites it directly · 455 of its ownK100889 Endoskeleton TCTitan Spine, LLC · 2010
- Descendant · 2 generations on · 289 of its ownK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- Descendant · 3 generations on · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · 2 generations on · 265 of its ownK141953 Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014 · Recalled
- Descendant · 3 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
Show all 11 generations
- Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations backK012254 VBROsteotech, Inc. · 2001
- 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 3 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 2 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 1 generation backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
Showing 5 of 554 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 554 · See all- K100889Endoskeleton TCTitan Spine, LLC · 2010 · cites it directly455descendants
- K121649Construx Mini Peek TI Spacer SystemOrthofix · 2012 · 2 generations on289descendants
- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · 3 generations on280descendants
- K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014 · 2 generations on265descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 3 generations on236descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −10 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −9 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −6 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −5 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −1 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| +1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| +2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| +3 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +2 | K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL | Titan Spine, LLC | 2014 | 2 |
| +3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 13 | 0 |
| 2016 | 17 | 0 |
| 2017 | 30 | 0 |
| 2018 | 33 | 0 |
| 2019 | 47 | 0 |
| 2020 | 47 | 0 |
| 2021 | 43 | 0 |
| 2022 | 56 | 0 |
| 2023 | 71 | 0 |
| 2024 | 60 | 0 |
| 2025 | 65 | 0 |
| 2026 | 56 | 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? (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 |
|---|---|---|---|
| * | K060762 | Aesculap Peek Vertebral Body Replacement SystemSummary page 1…Systems, Inc. believes that the Aesculap Cespace PEEK Spinal Implant System is substantially equivalent to the Aesculap PEEK VBR and Intervertebral Body Fusion Systems (K060762 & K071983), the Spinal Elements Crystal cervical interbody fusion devices (K073351). DEVICE DESCRIPTION The Aesculap CeSpace PEE… | 2006 |
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 1…Inc. believes that the Aesculap Cespace PEEK Spinal Implant System is substantially equivalent to the Aesculap PEEK VBR and Intervertebral Body Fusion Systems (K060762 & K071983), the Spinal Elements Crystal cervical interbody fusion devices (K073351). DEVICE DESCRIPTION The Aesculap CeSpace PEEK Spinal I… | 2008 |
| * | K073351 | CrystalSummary page 1…stantially equivalent to the Aesculap PEEK VBR and Intervertebral Body Fusion Systems (K060762 & K071983), the Spinal Elements Crystal cervical interbody fusion devices (K073351). DEVICE DESCRIPTION The Aesculap CeSpace PEEK Spinal Implant System is a cervical intervertebral body fusion device that is imp… | 2008 |
What descends from it? (554)
See all 5548 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 8 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 39 ancestors have a recall of any class.
- Of its descendants, K100889 (Titan Spine, LLC, 2010) has gone furthest, with 455 descendants of its own.
- 2 other devices also cite its predicate K060762.
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. 2009, 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 (T1 to L5) 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…
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 (T1 to L5) 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). DDD 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/K083311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083311: Aesculap Cespace Peek Intervertebral Body Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083311
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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