510(k) · Cleared
Recalled · Class II · 2023Lumbar Interbody Fusion System (OLLIF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Research Medical, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 25, 2018 as substantially equivalent to K090064 (Eminent Spine, 2009) and 1 other predicate after a 210-day review. Its family tree reaches back 8 generations to 1984. It has been recalled once.
- Decided
- Jul 25, 2018
- Review
- 210 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 34 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 deviceK173947 Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 2018
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) | K173947 | Lumbar Interbody Fusion System (OLLIF) | Advanced Research Medical, LLC | 2018 | — |
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 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 4…terbody Fusion System (OLLIF) PRIMARY PREDICATE DEVICE Python Interbody Fusion Device, Eminent Spine (K090064) REFERENCE PREDICATE DEVICE Buttress (Fang) Plate System, Eminent Spine… | 2009 |
| * | K090415 | Eminent Spine Buttress (Fang) Plate SystemSummary page 4…(K090064) REFERENCE PREDICATE DEVICE Buttress (Fang) Plate System, Eminent Spine (K090415) DEVICE DESCRIPTION The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) impl… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2023 | Class II | Z-1698-2024 | Device Design | Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 34 ancestors have a recall of any class.
- 33 other devices also cite its predicate K090064.
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. 2018, 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?
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173947: Lumbar Interbody Fusion System (OLLIF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173947
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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