510(k) · Cleared
ClearedAesculap Implant Systems Sibd Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 20, 2010 as substantially equivalent to K071983 (Aesculap Implant Systems, Inc., 2008) and 5 other predicates after a 120-day review. Its family tree reaches back 13 generations to 1984. 1 of the 537 devices in its family, counting itself, has a Class I recall. 461 later devices descend from it.
- Decided
- Jul 20, 2010
- Review
- 120 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 75 ancestors in all. 461 later devices descend from it, 1 citing it directly. 1 of the 537 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- This deviceK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- Descendant · cites it directly · 460 of its ownK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- Descendant · 2 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
- Descendant · 3 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- Descendant · 4 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- Descendant · 3 generations on · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- This deviceK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
Showing 5 of 461 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 461 · See all- K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011 · cites it directly460descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · 2 generations on459descendants
- K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 3 generations on368descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 4 generations on236descendants
- K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015 · 3 generations on220descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −1 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| 0 (this device) | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| +1 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| +2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| +3 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| +4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| +3 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 21 | 0 |
| 2019 | 31 | 0 |
| 2020 | 39 | 0 |
| 2021 | 42 | 1 |
| 2022 | 53 | 0 |
| 2023 | 57 | 0 |
| 2024 | 78 | 0 |
| 2025 | 61 | 0 |
| 2026 | 50 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 1…QUIVALENCE Aesculap® Implant Systems, Inc. believes that the SIBD Spinal System is substantially equivalent to the Aesculap® Implant Systems PEEK Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 1…s, Inc. believes that the SIBD Spinal System is substantially equivalent to the Aesculap® Implant Systems PEEK Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine St… | 2007 |
| * | K081395 | Solitaire Peek-Optima Anterior Spinal SystemSummary page 1…ally equivalent to the Aesculap® Implant Systems PEEK Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STA… | 2008 |
| * | K082262 | LDR Spine Roi Interbody Fusion SystemSummary page 1…Spinal Implant System (K071983), Synthes SynFix-LR Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STALIF TT System (K073109). DEVICE DESCRIPTION The Aes… | 2009 |
| * | K091301 | Life Spine Stand-Alone Spacer SystemSummary page 1…Spacer (K072253), Biomet Spine Solitaire Anterior Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STALIF TT System (K073109). DEVICE DESCRIPTION The Aesculap® iImplant Systems SIBD Spinal System is an imp… | 2009 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…or Spinal System (K081395), the LDR Spine ROI Interbody Fusion System (K082262), the Life Spine Stand Alone Spacer System (K091301), and the Surgicraft STALIF TT System (K073109). DEVICE DESCRIPTION The Aesculap® iImplant Systems SIBD Spinal System is an implantable spinal device manufactured from polyet… | 2008 |
What descends from it? (461)
See all 4611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111122 | Aesculap Sibd XP Spinal System | 2011 | 460 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 12 companies; a new generation was cleared every 9 months on median.
- 10 of the 75 ancestors have a recall of any class.
- Of its descendants, K111122 (Aesculap Implant Systems, Inc., 2011) has gone furthest, with 460 descendants of its own.
- 11 other devices also cite its predicate K071983.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used. As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is…
Read the full statement (139 words)
The SIBD Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplement fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with-degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be 'skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100802: Aesculap Implant Systems Sibd Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100802
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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