510(k) · Cleared
ClearedXiphos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Difusion Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 7, 2013 as substantially equivalent to K100042 (Difusion Technologies, 2010) and 2 other predicates after a 43-day review. Its family tree reaches back 8 generations to 1984. 14 later devices descend from it.
- Decided
- Feb 7, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 37 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- 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 backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 1 generation backK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008 · Recalled
- This deviceK123969 XiphosDifusion Technologies · 2013
- Descendant · cites it directly · 13 of its ownK133340 Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
- Descendant · 2 generations on · 12 of its ownK153123 Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 11 of its ownK161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 3 generations on · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 4 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014 · cites it directly13descendants
- K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016 · 2 generations on12descendants
- K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine · 2016 · 3 generations on11descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · 3 generations on9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 4 generations on7descendants
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 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −1 | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | 1 |
| 0 (this device) | K123969 | Xiphos | Difusion Technologies | 2013 | — |
| +1 | K133340 | Spineworks Anterior Lumbar Device | Spineworks, LLC | 2014 | — |
| +2 | K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016 | — |
| +3 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +4 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
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 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K100042 | Difusion Technologies Xiphos Interbody Fusion SystemSummary page 2…Page 15 K123969 Page 2of 2 Predicate Devices: DiFusion Technologies (K1 00042) Eminent Spine LLC (K090064) Theken Spine (K080822) Performance Data: Mechanical tes… | 2010 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 2…K123969 Page 2of 2 Predicate Devices: DiFusion Technologies (K1 00042) Eminent Spine LLC (K090064) Theken Spine (K080822) Performance Data: Mechanical testing of the worst case XIPHOSTM ALIF was performe… | 2009 |
| * | K080822 | VU Apod Intervertabral Body Fusion DeviceSummary page 2…K123969 Page 2of 2 Predicate Devices: DiFusion Technologies (K1 00042) Eminent Spine LLC (K090064) Theken Spine (K080822) Performance Data: Mechanical testing of the worst case XIPHOSTM ALIF was performed according to ASTM F20… | 2008 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133340 | Spineworks Anterior Lumbar Device | 2014 | 13 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K133340 (Spineworks, LLC, 2014) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K100042.
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. 2013, 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?
When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS Interbody Fusion 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 (DDD) with up to Grade I spondylolisthesis. DDD is defined as…
Read the full statement (208 words)
When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS Interbody Fusion 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 (DDD) with up to Grade I spondylolisthesis. DDD 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.
When used as a vertebral body replacement device, the DiFUSION Technologies XIPHOS 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 XIPHOS System is intended for use in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomnechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DiFUSION Technologies XIPHOS System is intended to be used with autograft or allograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123969: Xiphos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123969
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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