510(k) · Cleared

Cleared

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

K171595510(k) TraditionalCleared Aug 2, 201763-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

Medacta International S.A. · OUR Sacroiliac Joint Fixation

Cleared on Aug 2, 2017 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 5 other predicates after a 63-day review. Its family tree reaches back 6 generations to 1990. 35 later devices descend from it.

Decided: Aug 2, 2017
Review: 63 days
Class: Class II
Product code: OUR
Recalls: None
Predicates: 6

Its longest line of descent runs back 6 generations to K903810 (1990). 12 ancestors in all. 35 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 6 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
5 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
4 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
3 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
2 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
1 generation backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
This deviceK171595 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
Descendant · cites it directly · 21 of its ownK193083 M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A. · 2019
Descendant · 2 generations on · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled
Descendant · 3 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
Descendant · 3 generations on · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
Descendant · cites it directly · 6 of its ownK190025 EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC · 2019

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2019high 9 (2023) · low 1 (2020)2026

Most influential descendants

Showing 5 of 35 · See all

K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A. · 2019 · cites it directly21descendants
K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · 2 generations on17descendants
K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 3 generations on15descendants
K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · 3 generations on14descendants
K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC · 2019 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K903810	Ace Cannulated Self Tapping Cancellous Bone Screw	Ace Medical Co.	1990	—
−5	K051296	Sijf Cannulated Screw System	Depuy Spine, Inc.	2005	—
−4	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
−3	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
−2	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
−1	K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	—
0 (this device)	K171595	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System	Medacta International S.A.	2017	—
+1	K193083	M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System	Medacta International S.A.	2019	—
+2	K203247	iFuse-TORQ™ Implant System	SI-BONE, Inc.	2021	1
+3	K213667	iFuse-TORQ® Implant System	SI-BONE, Inc.	2022	—
+3	K222605	iFuse TORQ® Implant System	SI-BONE, Inc.	2022	—
+1	K190025	EVOL® -SI Joint Fusion System	Cutting Edge Spine, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0
2002	2	0
2009	1	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2020	1	0
2021	2	0
2022	5	0
2023	9	0
2024	5	0
2025	5	0
2026	6	0

FIG. 1 — Lineage of K171595, 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

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What was it cleared against? (6)

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
*	K021932	Synthes 6.5 MM Cannulated Screw Summary page 4 …e Device Substantial equivalence is claimed to the following devices: Primary Predicate: Synthes 6.5 mm Cannulated Screw (Also referred to as Synthes Cannulated Screws), K021932, Synthes (USA) Additional Predicates: Pelvic Trauma and Washers  Synthes 7.0/7.3 mm Cannulated Screws (Also referred to as S…	Synthes (Usa)	2002	7
*	K962011	Synthes 7.0/7.3 MM Cannulated Screws Summary page 4 …021932, Synthes (USA) Additional Predicates: Pelvic Trauma and Washers  Synthes 7.0/7.3 mm Cannulated Screws (Also referred to as Synthes Cannulated Screws), K962011, Synthes (USA)  Asnis III Cannulated Screw System, K000080, Howmedica Osteonics Corp.  Modification to Asnis III Cannulat…	Synthes (Usa)	1996	—
*	K000080	Asnis Iii Cannulated Screw System Summary page 4 …Washers  Synthes 7.0/7.3 mm Cannulated Screws (Also referred to as Synthes Cannulated Screws), K962011, Synthes (USA)  Asnis III Cannulated Screw System, K000080, Howmedica Osteonics Corp.  Modification to Asnis III Cannulated Screw System, K024060, Howmedica Osteonics Corp. Sac…	Howmedica Osteonics Corp.	2000	1
*	K024060	Modification to Asnis Iii Cannulated Screw System Summary page 4 …Screws), K962011, Synthes (USA)  Asnis III Cannulated Screw System, K000080, Howmedica Osteonics Corp.  Modification to Asnis III Cannulated Screw System, K024060, Howmedica Osteonics Corp. Sacro-Iliac Joint Screws  SI-LOK Sacroiliac Joint Fixation System, K112028, Globus Medical…	Howmedica Osteonics Corp.	2002	—
*	K112028	SI-Lok Sacroiliac Joint Fixation System Summary page 4 … Modification to Asnis III Cannulated Screw System, K024060, Howmedica Osteonics Corp. Sacro-Iliac Joint Screws  SI-LOK Sacroiliac Joint Fixation System, K112028, Globus Medical, Inc.  SImmetry Sacroiliac Joint Fusion System, K130092, Zyga Technology, Inc.…	Globus Medical, Inc.	2011	—
*	K130092	Simmetry Sacroiliac Joint Fusion System Summary page 4 …steonics Corp. Sacro-Iliac Joint Screws  SI-LOK Sacroiliac Joint Fixation System, K112028, Globus Medical, Inc.  SImmetry Sacroiliac Joint Fusion System, K130092, Zyga Technology, Inc.…	Zyga Technology, Inc.	2013	—
†	K082792	Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems	Medacta International S.A.	2008	1
†	K091967	Medacta Bipolar Head	Medacta International S.A.	2010	—

Also cleared against K021932: 61 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K193083	M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System	Medacta International S.A.	2019	21
K190025	EVOL® -SI Joint Fusion System	Cutting Edge Spine, LLC	2019	6
K191995	S4 Screw System	Subchondral Solutions, Inc.	2020	2
K234048	M.U.S.T. Pedicle Screw System - Extension	Medacta International S.A.	2024	1
K212755	SIGNUS SACRONAIL® Transsacral Stabilization System	Signus Medizintechnik GmbH	2022	0

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 27 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
2 of the 12 ancestors have a recall of any class.
Of its descendants, K193083 (Medacta International S.A., 2019) has gone furthest, with 21 descendants of its own.
61 other devices also cite its predicate K021932.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacroiliac joint disruptions and degenerative sacroiliitis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171595: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171595

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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