510(k) · Cleared
ClearedDeroyal Spine Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 3, 2014 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 5 other predicates after a 273-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Feb 3, 2014
- Review
- 273 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K841189 (1984). 44 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 2 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 1 generation backK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- This deviceK131292 Deroyal Spine Spacer SystemDeroyal Industries, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −1 | K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | 2009 | 1 |
| 0 (this device) | K131292 | Deroyal Spine Spacer System | Deroyal Industries, Inc. | 2014 | — |
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 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 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 MAX? 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? (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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…K131292 page 2 of 2 Predicate Devices: Lumbar I/F Cage@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064)… | 1999 |
| * | K050449 | Quantum Vertebral Body ReplacementSummary page 2…page 2 of 2 Predicate Devices: Lumbar I/F Cage@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Per… | 2005 |
| * | K071724 | LucentSummary page 2…page 2 of 2 Predicate Devices: Lumbar I/F Cage@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Performance… | 2007 |
| * | K081968 | Modification to LucentSummary page 2…page 2 of 2 Predicate Devices: Lumbar I/F Cage@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Performance Data: Mec… | 2008 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 2…Predicate Devices: Lumbar I/F Cage@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Performance Data: Mechanical testing of the worst case Spine Spacer was performed… | 2009 |
| * | K043479 | MC+ Partial VBRSummary page 2…age@ (P960025) Lucento (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Performance Data: Mechanical testing of the worst case Spine Spacer was performed according to ASTM F207… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 44 ancestors have a recall of any class.
- 98 other devices also cite its predicate P960025.
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. 2014, 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?
Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (204 words)
Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine.
Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from Ti to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131292: Deroyal Spine Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131292
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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