510(k) · Cleared
Recalled · Class II · 2016Oracle Spacer, Opal Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 26, 2007 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) after an 86-day review. Its family tree reaches back 1 generation to 1999. 1 of the 1,057 devices in its family, counting itself, has a Class I recall. 1,055 later devices descend from it. It has been recalled once.
- Decided
- Dec 26, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to P960025 (1999). 1,055 later devices descend from it, 29 citing it directly. 1 of the 1,057 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- This deviceK072791 Oracle Spacer, Opal SpacerSynthes Spine · 2007
- Descendant · cites it directly · 848 of its ownK081177 Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
- Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
Showing 5 of 1,055 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,055 · See all- K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc. · 2008 · cites it directly848descendants
- K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · cites it directly762descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 2 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| 0 (this device) | K072791 | Oracle Spacer, Opal Spacer | Synthes Spine | 2007 | — |
| +1 | K081177 | Blackstone Medical, Inc., Pillar Spacer System | Blackstone Medical, Inc. | 2008 | — |
| +1 | K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | Thompson Mis, Inc. | 2011 | — |
| +2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 11 | 0 |
| 2012 | 14 | 0 |
| 2013 | 16 | 0 |
| 2014 | 37 | 0 |
| 2015 | 36 | 0 |
| 2016 | 65 | 0 |
| 2017 | 84 | 0 |
| 2018 | 82 | 0 |
| 2019 | 87 | 0 |
| 2020 | 99 | 0 |
| 2021 | 81 | 1 |
| 2022 | 78 | 0 |
| 2023 | 100 | 0 |
| 2024 | 101 | 0 |
| 2025 | 81 | 0 |
| 2026 | 76 | 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? (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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…060 - Spinal Vertebral Body Replacement Device Orthopaedic and Rehabilitation Devices Panel Product Code MQP Class II Predicates: Depuy Acromed, Inc., Lumbar I/F Cage (P960025) The Synthes Oracle Spacer is a radiolucent, oval-shaped interbody fusion device used in conjunction with supplemental fixation… | 1999 |
What descends from it? (1,055)
See all 1,05529 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081177 | Blackstone Medical, Inc., Pillar Spacer System | 2008 | 848 |
| K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | 2011 | 762 |
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K113478 | Plif Cage | 2012 | 269 |
| K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 | 251 |
| K122989 | Biomet Lateral Spacer System | 2012 | 171 |
| K123180 | Falcon Spacer | 2013 | 147 |
| K122639 | Synthes Syncage Evolution Spacer | 2013 | 143 |
| K170676 | HD Lumbar Interbody System | 2017 | 122 |
| K112664 | Zavation Ibf Systems | 2011 | 37 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2016 | Class II | Z-1392-2016 | Labeling mix-ups | The label on the outer packaging does not match the product inside and intended use of the 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2007, 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?
Synthes Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Oracle Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These…
Read the full statement (413 words)
Synthes Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Oracle Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
*The Oracle Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click’X) and small stature USS.
Synthes Oracle Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures for the treatment of tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Oracle Spacer is intended to be used with Synthes internal fixation systems, e.g., Pangea, USS (including Click’X), Small Stature USS, ATLP, TSLP, and VentroFix. The interior of the spacer can be packed with bone (autograft or allograft).
The Oracle Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
*The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS (including Click’X) and small stature USS.
The OPAL Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to.replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The OPAL Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the OPAL Spacer system can be packed with bone.
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/K072791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072791: Oracle Spacer, Opal Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072791
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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