510(k) · Cleared

Cleared

Simmetry Sacroiliac Joint Fusion System

K130092510(k) SpecialCleared Feb 27, 201343-day reviewClass II21 CFR 888.3040

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

Zyga Technology, Inc. · OUR Sacroiliac Joint Fixation

Cleared on Feb 27, 2013 as substantially equivalent to K111801 (Zyga Technology, Inc., 2011) after a 43-day review. Its family tree reaches back 5 generations to 1990. 85 later devices descend from it.

Decided: Feb 27, 2013
Review: 43 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K903810 (1990). 9 ancestors in all. 85 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
4 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
3 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
2 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
1 generation backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
This deviceK130092 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2013
Descendant · cites it directly · 63 of its ownK141549 SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015
Descendant · 2 generations on · 42 of its ownK151818 SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015
Descendant · cites it directly · 35 of its ownK171595 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
Descendant · 3 generations on · 31 of its ownK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
Descendant · 4 generations on · 29 of its ownK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2014high 17 (2023) · low 1 (2014)2026

Most influential descendants

Showing 5 of 85 · See all

K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015 · cites it directly63descendants
K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2015 · 2 generations on42descendants
K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017 · cites it directly35descendants
K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019 · 3 generations on31descendants
K200696FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 4 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw	Ace Medical Co.	1990	—
−4	K051296	Sijf Cannulated Screw System	Depuy Spine, Inc.	2005	—
−3	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
−2	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
−1	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
0 (this device)	K130092	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2013	—
+1	K141549	SImmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2015	—
+2	K151818	SImmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2015	—
+1	K171595	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	Medacta International S.A.	2017	—
+3	K183342	SambaScrew 3D SI Fusion System	Orthofix, Inc.	2019	—
+4	K200696	FIREBIRD SI Fusion System	Orthofix, Inc.	2020	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	2	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	2	0
2016	2	0
2017	1	0
2018	1	0
2019	4	0
2020	5	0
2021	8	0
2022	11	0
2023	17	0
2024	15	0
2025	9	0
2026	9	0

FIG. 1 — Lineage of K130092, 1990–2026Source: 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.

Planning a device in OUR? 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 OUR device

#1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—

Also cleared against K111801: 2 other devices →

What descends from it? (85)

See all 85

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

Number	Device	Applicant	Decided	Descendants
K141549	SImmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2015	63
K171595	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	Medacta International S.A.	2017	35
K140079	Silex Sacroiliac Joint Fusion System	X-Spine Systems, Inc.	2014	12

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 23 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
2 of the 9 ancestors have a recall of any class.
Of its descendants, K141549 (Zyga Technology, Inc., 2015) has gone furthest, with 63 descendants of its own.
2 other devices also cite its predicate K111801.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OUR

14in 2025

2007high 20 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUR

97in 2025

2007high 168 (2016) · low 27 (2011)2026

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

Recalls per year · OUR

1in 2025

2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUR

10in 2025

2007high 175 (2019) · low 0 (2007)2025

MAUDE reports naming product code OUR, 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	0	—	0	0
2008	1	—	0	0
2009	1	—	0	0
2010	1	—	0	0
2011	3	27	0	6
2012	2	—	0	81
2013	4	103	0	96
2014	3	91	0	146
2015	8	111	0	119
2016	6	168	0	122
2017	4	120	0	157
2018	7	82	0	137
2019	7	89	0	175
2020	7	88	0	148
2021	9	85	0	154
2022	14	149	0	23
2023	20	55	0	7
2024	15	74	0	15
2025	14	97	1	10
2026	6	98	1	—

What is it indicated for?

The Simmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130092: Simmetry Sacroiliac Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130092

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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