510(k) · Cleared

Cleared

Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss

K022949510(k) TraditionalCleared Mar 24, 2003200-day reviewClass II21 CFR 888.3070

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

Synthes (Usa) · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Mar 24, 2003 after a 200-day review. The FDA summary names no predicate by number. 2 of the 868 devices in its family, counting itself, have a Class I recall. 867 later devices descend from it.

Decided: Mar 24, 2003
Review: 200 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 0

867 later devices descend from it, 21 citing it directly. 2 of the 868 devices in this family, counting this one, have a Class I recall.

This deviceK022949 Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSynthes (Usa) · 2003
Descendant · cites it directly · 659 of its ownK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
Descendant · cites it directly · 551 of its ownK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
Descendant · 2 generations on · 549 of its ownK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
Descendant · 2 generations on · 547 of its ownK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006

Showing 5 of 867 descendants. See all descendants

Descendants cleared per year

2004high 85 (2023) · low 2 (2005)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix System2 generations on · 2010
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 867 · See all

K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · cites it directly659descendants
K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
K040442Protex Stabilization SystemGlobus Medical, Inc. · 2004 · cites it directly551descendants
K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005 · 2 generations on549descendants
K061202Revere Stabilization SystemGlobus Medical, Inc. · 2006 · 2 generations on547descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022949	Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss	Synthes (Usa)	2003	—
+1	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
+2	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
+1	K040442	Protex Stabilization System	Globus Medical, Inc.	2004	—
+2	K052069	Protex Stabilization System with Additional Componentes	Globus Medical, Inc.	2005	—
+2	K061202	Revere Stabilization System	Globus Medical, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	2	0
2006	4	0
2007	2	0
2008	9	0
2009	10	0
2010	12	1
2011	14	0
2012	29	0
2013	41	0
2014	46	0
2015	51	0
2016	48	0
2017	56	0
2018	56	0
2019	42	0
2020	53	0
2021	42	1
2022	59	0
2023	85	0
2024	75	0
2025	63	0
2026	65	0

FIG. 1 — Lineage of K022949, 2003–2026Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (867)

See all 867

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

Number	Device	Applicant	Decided	Descendants
K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	659
K040442	Protex Stabilization System	Globus Medical, Inc.	2004	551
K082914	Clampfix	Synthes Spine	2008	350
K090605	Clampfix	Synthes (Usa)	2009	349
K100634	Synthes Matrix System	Synthes (Usa)	2010	316
K033090	Icon Polyaxial Pedicle Screw System	Alphatec Mfg., Inc.	2004	180
K120270	Venus Spinal Fixation System	L&K BIOMED Co., Ltd.	2012	111
K133746	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	2014	67
K121115	M.U.S.T Pedicle Screw System	Medacta International	2012	43
K120899	Range Spinal System, Unit Rod	K2m, Inc.	2012	35

Has anything in its family been recalled? (2 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.

K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K082572 (Synthes Spine, 2008) has gone furthest, with 659 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

Posterior Components When used as posterior pedicle screw fixation system in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components, and the Dual-Opening USS and Synthes Small Stature USS (which includes small stature), is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar…

Read the full statement (427 words)

Posterior Components

When used as posterior pedicle screw fixation system in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components, and the Dual-Opening USS and Synthes Small Stature USS (which includes small stature), is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous spinal fusion, and pseudoarthrosis.

When treating patient's with Degenerative Disc Disease (ODD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

In addition, in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components and the Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients) is intended for the treatment of severe spondylolisthesis (grade 3 and 4) of the L5-Sl vertebra in patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation are L3-S2/ilium.

When used as a posterior non-pedicle screw fixation system, in skeletally mature patients, the Synthes USS, and the Dual-Opening and Small Stature USS (which includes small stature and pediatric patients) are intended for the treatment of degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease) fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion.

Anterior Components

When used as an anteriolateral system, in skeletally mature patients, the Synthes USS, Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients), is intended for anteriolateral screw and/or staple fixation for the following indications: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion (levels T8-L5).

In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFixTMSystem. When used with 5.0/6.0 mm parallel connectors the Small Stature USS can be linked to the USS and Dual-Opening USS.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022949 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022949

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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