510(k) · Cleared

Recalled · Class I · 2012

Ardis Spacer

K073202510(k) TraditionalCleared Jan 30, 200878-day reviewClass II21 CFR 888.3080Recalls 1 (1 Class I)

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

Abbott Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 30, 2008 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) after a 78-day review. Its family tree reaches back 1 generation to 1996. 1 of the 646 devices in its family, counting itself, has a Class I recall. 644 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Jan 30, 2008
Review: 78 days
Class: Class II
Product code: MAX
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to P950002 (1996). 644 later devices descend from it, 11 citing it directly. 1 of the 646 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
This deviceK073202 Ardis SpacerAbbott Spine, Inc. · 2008
Descendant · cites it directly · 476 of its ownK113561 TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012 · Recalled
Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
Descendant · cites it directly · 343 of its ownK103111 Forza Spacer SystemOrthofix, Inc. · 2011 · Recalled
Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 644 descendants. See all descendants

Descendants cleared per year

2008high 80 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 644 · See all

K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012 · cites it directly476descendants
K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
K103111Forza Spacer SystemOrthofix, Inc. · 2011 · cites it directly343descendants
K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P950002	Bak Interbody Fusion System	Zimmer Spine, Inc.	1996	—
0 (this device)	K073202	Ardis Spacer	Abbott Spine, Inc.	2008	—
+1	K113561	TM Ardis Interbody System TM Ardis Interbody System Instrumenation	Zimmer Trabecular Metal Technology	2012	2
+2	K150481	Cascadia Interbody System	K2m, Inc.	2015	3
+1	K103111	Forza Spacer System	Orthofix, Inc.	2011	1
+3	K160125	Cascadia Interbody System	K2m	2016	—
+3	K163230	NuVasive Modulus XLIF Interbody System	Nu Vasive, Incorporated	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2010	1	0
2011	5	0
2012	4	0
2013	3	0
2014	5	0
2015	6	0
2016	19	0
2017	41	0
2018	38	0
2019	47	0
2020	65	0
2021	57	0
2022	65	0
2023	80	0
2024	79	0
2025	68	0
2026	59	0

FIG. 1 — Lineage of K073202, 1996–2026Source: 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? (1)

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
*	P950002	Bak Interbody Fusion System Summary page 1 …Spinal Intervertebral Body Fusion Device CLASSIFICATION REFERENCE: 21 CFR § 888.3080 PREDICATE DEVICE: BAK TM Interbody Fusion System (P950002) DEVICE DESCRIPTION: ArdiSTM Spacer is a hollow device intended for use as a…	Zimmer Spine, Inc.	1996	—

Also cleared against P950002: 34 other devices →

What descends from it? (644)

See all 644

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

Number	Device	Applicant	Decided	Descendants
K113561	TM Ardis Interbody System TM Ardis Interbody System Instrumenation	Zimmer Trabecular Metal Technology	2012	476
K103111	Forza Spacer System	Orthofix, Inc.	2011	343
K080588	Scient'x Tribeca VBR	Scient'X USA, Inc.	2008	250
K132790	Infix Anterior Lumbar System	Zimmer Spine, Inc.	2013	28
K133184	Ardis Interbody System	Zimmer Spine, Inc.	2014	20
K120203	TM-400 Device	Zimmer Trabecular Metal Technology, Inc.	2012	20
K073502	Vertebron VBR System	Vertebron, Inc.	2008	12
K110442	Nanovis Intervertebral Body Fusion System	Nanovis, LLC	2011	10
K190563	4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…	Solco Biomedical Co., Ltd.	2019	2
K131242	Ardis Interbody System	Zimmer Spine, Inc.	2013	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 12, 2012	Class I	Z-0594-2013	Device Design	Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K113561 (Zimmer Trabecular Metal Technology, 2012) has gone furthest, with 476 descendants of its own.
34 other devices also cite its predicate P950002.

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. 2008, 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?

The ArdisTM Spacer is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, Patients with previous non-fusion…

Read the full statement (118 words)

The ArdisTM Spacer is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073202: Ardis Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073202

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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