510(k) · Cleared

Cleared

Difusion Technologies Xiphos Interbody Fusion System

K100042510(k) TraditionalCleared Oct 1, 2010266-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Difusion Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Oct 1, 2010 as substantially equivalent to P970015 (Sofamor Danek, 1999) and 4 other predicates after a 266-day review. Its family tree reaches back 7 generations to 1984. 1 of the 892 devices in its family, counting itself, has a Class I recall. 864 later devices descend from it.

Decided: Oct 1, 2010
Review: 266 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K841189 (1984). 27 ancestors in all. 864 later devices descend from it, 6 citing it directly. 1 of the 892 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
1 generation backK043479 MC+ Partial VBRLdr Spine USA · 2005
This deviceK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010
Descendant · cites it directly · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Descendant · 3 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Descendant · 3 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013

Showing 5 of 864 descendants. See all descendants

Descendants cleared per year

2011high 96 (2024) · low 1 (2011)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 864 · See all

K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · cites it directly762descendants
K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on723descendants
K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 3 generations on709descendants
K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K841189	Oec/Rezaian Spinal Fixator	Orthopedic Equipment Co., Inc.	1984	—
−6	K990148	Stackable Cage System	Depuy Motech Acromed	1999	—
−5	K003043	Surgical Titanium Mesh System	Depuyacromed	2001	—
−4	K022793	Tetris Spinal Implant	Signus Medical, LLC	2003	—
−3	K031757	Peek Tetris Spinal Implant	Signus Medical, LLC	2003	—
−2	K033109	Ellys and Aurys Vertebral Body Replacements	Scient'X	2004	—
−1	K043479	MC+ Partial VBR	Ldr Spine USA	2005	—
0 (this device)	K100042	Difusion Technologies Xiphos Interbody Fusion System	Difusion Technologies	2010	—
+1	K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	—
+2	K120368	Capstone Control Spinal System	Medtronic Sofamor Danek USA, Inc.	2012	—
+3	K121760	Capstone Spinal System	Medtronic Sofamor Danek USA, Inc.	2012	—
+3	K123027	Capstone (R) Spinal System	Medtronic Sofamor Danek, Inc.	2013	—
+1	K131082	Interform Interbody Cage System	Next Orthosurgical	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1999	2	0
2000	1	0
2001	7	0
2002	3	0
2003	1	0
2004	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	5	0
2013	9	0
2014	15	0
2015	26	0
2016	43	0
2017	64	0
2018	67	0
2019	73	0
2020	84	0
2021	71	1
2022	72	0
2023	92	0
2024	96	0
2025	78	0
2026	68	0

FIG. 1 — Lineage of K100042, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	P970015	Inter Fix Threaded Fusion Device Summary page 1 …assified cages, as well as various cleared VBR systems: - LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9110/03) - BAK® Cage (…	Sofamor Danek	1999	1
*	P950002	Bak Interbody Fusion System Summary page 1 …ek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9110/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03) - RAY® Threaded Fusion Cage (P950019, Stryker, Approved…	Zimmer Spine, Inc.	1996	—
*	P950019	Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation Summary page 1 …Approved 9110/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03) - RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/0 3) - Lumbar I/F Cage (P960025, D…	Stryker Spine	1996	1
*	P960025	Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws Summary page 1 …- RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/0 3) - Lumbar I/F Cage (P960025, DePuy, Approved 314/05) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) === Page 2 =…	Depuy Spine, Inc.	1999	—
*	K043479	MC+ Partial VBR Summary page 1 …9/4/0 3) - Lumbar I/F Cage (P960025, DePuy, Approved 314/05) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) DEVICE DESCRIPTION The DiFUSION Technologies XIPHOS Interbody Fusion System is compr…	Ldr Spine USA	2005	—

Also cleared against P970015: 18 other devices →

What descends from it? (864)

See all 864

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111512	Bonebac T-Plif Intervertebral Body Fusion Device System	Thompson Mis, Inc.	2011	762
K131082	Interform Interbody Cage System	Next Orthosurgical	2013	595
K113138	Aleutian System	K2m, Inc.	2012	549
K123969	Xiphos	Difusion Technologies	2013	14
K151819	Integrity Spine Lumbar Interbody Fusion System	Integrity Spine Lumbar Interbody Fusion System	2015	4
K190544	XIHPOS™ ZFUZE™ Interbody Fusion System	Difusion Technologies	2019	0

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.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
5 of the 27 ancestors have a recall of any class.
Of its descendants, K111512 (Thompson Mis, Inc., 2011) has gone furthest, with 762 descendants of its own.
18 other devices also cite its predicate P970015.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)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 DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertelbral 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. DOID is defined as back pain of…

Read the full statement (199 words)

Intervertebral Body Fusion Device:

The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertelbral 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. 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.

Vertebral Body Replacement Device:

The DiFUSION Technologies XIPHOS System of implants 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 biornechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100042 · printed Nov 4, 2026

Cite this page

510(k) Report. “K100042: Difusion Technologies Xiphos Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100042

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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