510(k) · Cleared
ClearedTwin Peaks Lumbar Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualgenix, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 18, 2012 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 2 other predicates after a 216-day review. Its family tree reaches back 9 generations to 1984. 1 of the 27 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 18, 2012
- Review
- 216 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 26 ancestors in all. No later device cites it as a predicate yet. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK112696 Twin Peaks Lumbar CageQualgenix, LLC · 2012
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK112696 Twin Peaks Lumbar CageQualgenix, LLC · 2012
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −5 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K112696 | Twin Peaks Lumbar Cage | Qualgenix, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2010 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…Lumbar Cage was shown to be substantially equivalent to previously cleared devices, including the DePuy Spine Lumbar Cages (K081917) SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage (K080588), and has the s… | 2009 |
| * | K101720 | Juliet OL Our reading of the summary gave K101710, FDA’s number for Luxatemp Ultra /Star (Dmg USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SpineArt Juliet Cage”. | 2010 |
| * | K080588 | Scient'x Tribeca VBRSummary page 1…including the DePuy Spine Lumbar Cages (K081917) SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage (K080588), and has the same indications for use, design, and function. For example, the Qualgenix… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- 35 other devices also cite its predicate K081917.
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. 2012, 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 Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from 12 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112696: Twin Peaks Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112696
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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