510(k) · Cleared
Recalled · Class II · 2013Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 1, 2008 as substantially equivalent to K060762 (Aesculap, Inc., 2006) and 2 other predicates after a 287-day review. Its family tree reaches back 10 generations to 2001. 1 of the 826 devices in its family, counting itself, has a Class I recall. 788 later devices descend from it. It has been recalled once.
- Decided
- May 1, 2008
- Review
- 287 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K003155 (2001). 37 ancestors in all, the oldest K841189 (1984). 788 later devices descend from it, 12 citing it directly. 1 of the 826 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations between
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 1 generation backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- This deviceK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008
- Descendant · cites it directly · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- Descendant · cites it directly · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- Descendant · 2 generations on · 460 of its ownK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- Descendant · 3 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
- Descendant · 2 generations on · 455 of its ownK100889 Endoskeleton TCTitan Spine, LLC · 2010
Show all 10 generations
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations backK012254 VBROsteotech, Inc. · 2001
- 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 5 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 4 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 1 generation backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- This deviceK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008
Showing 5 of 788 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 788 · See all- K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · cites it directly554descendants
- K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · cites it directly461descendants
- K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011 · 2 generations on460descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · 3 generations on459descendants
- K100889Endoskeleton TCTitan Spine, LLC · 2010 · 2 generations on455descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −9 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −8 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −5 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −4 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | — |
| +1 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| +1 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| +2 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| +3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| +2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 16 | 0 |
| 2015 | 19 | 0 |
| 2016 | 28 | 0 |
| 2017 | 48 | 0 |
| 2018 | 53 | 0 |
| 2019 | 69 | 0 |
| 2020 | 74 | 0 |
| 2021 | 69 | 1 |
| 2022 | 72 | 0 |
| 2023 | 87 | 0 |
| 2024 | 90 | 0 |
| 2025 | 76 | 0 |
| 2026 | 69 | 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.
1 device in this family has a Class I recall. 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? (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…BSTANTIAL EQUIVALENCE Aesculap®5 Implant Systems, Inc. believes that the Aesculap PEEK Spinal Implant System is substantially equivalent to the Aesculap PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071 724 & K073348). DEVICE DESCRIPTION The Aesculap PE… | 2006 |
| * | K071724 | Lucent Cleared while this submission was under review Summary page 1…PEEK Spinal Implant System is substantially equivalent to the Aesculap PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071 724 & K073348). DEVICE DESCRIPTION The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted… | 2007 |
| * | K073348 | Lucent Magnum Cleared while this submission was under review Summary page 1…l Implant System is substantially equivalent to the Aesculap PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071 724 & K073348). DEVICE DESCRIPTION The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the… | 2007 |
What descends from it? (788)
See all 78812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | 2009 | 554 |
| K100802 | Aesculap Implant Systems Sibd Spinal System | 2010 | 461 |
| K113478 | Plif Cage | 2012 | 269 |
| K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 | 251 |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 | 20 |
| K132421 | Aesculap Peek XP Spinal Implant System | 2014 | 14 |
| K172185 | Tyber Medical PT Interbody Spacer System | 2017 | 7 |
| K181970 | MectaLIF Posterior Extension | 2018 | 2 |
| K181899 | Roccia® Plif | 2018 | 0 |
| K143450 | Ackermann Intervertebral Body Fusion Device | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2013 | Class II | Z-1806-2013 | Employee error | Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K083311 (Aesculap Implant Systems, Inc., 2009) has gone furthest, with 554 descendants of its own.
- 2 other devices also cite its predicate K060762.
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. 2008, 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?
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 (305 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 A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) 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. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months 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/K071983 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071983: Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071983
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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