510(k) · Cleared
ClearedHelena System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Royal Oak Medical Devices · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 21, 2011 as substantially equivalent to P950019 (Stryker Spine, 1996) and 4 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Apr 21, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K841189 (1984). 33 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 deviceK110177 Helena SystemRoyal Oak Medical Devices · 2011
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) | K110177 | Helena System | Royal Oak Medical Devices | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 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? (5)
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 |
|---|---|---|---|
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…Predicate devices include various cleared interbody fusion systems: - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Eminent Spine System (K09006… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…systems: - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Eminent Spine System (K090064) - SpineSmith Cynch System… | 1999 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 1…- RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Eminent Spine System (K090064) - SpineSmith Cynch System (K090376) - BAK Vista (P950002)… | 2009 |
| * | K090376 | Spinesmith Cynch Spinal SystemSummary page 1…- Lumbar I/F Cage (P960025) - Eminent Spine System (K090064) - SpineSmith Cynch System (K090376) - BAK Vista (P950002) v'I 1O I-T+… | 2009 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…- Eminent Spine System (K090064) - SpineSmith Cynch System (K090376) - BAK Vista (P950002) v'I 1O I-T+ F-'-… | 1996 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 33 ancestors have a recall of any class.
- 37 other devices also cite its predicate P950019.
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. 2011, 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?
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to
SI, 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 (ODD) with up to Grade I spondylolisthesis or retrolisthesis at the
involved level(s). DOID is defined as back pain of discogenic origin with degeneration of the
disc confirmed by 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/K110177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110177: Helena System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110177
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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