510(k) · Cleared

Recalled · Class II · 2013

Click'x

K992739510(k) TraditionalCleared Feb 8, 2000176-day reviewClass II21 CFR 888.3070Recalls 1

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

Synthes Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 8, 2000 as substantially equivalent to K990745 (Synthes Spine, 1999) after a 176-day review. Its family tree reaches back 1 generation to 1999. 2 of the 914 devices in its family, counting itself, have a Class I recall. 912 later devices descend from it. It has been recalled once.

Decided: Feb 8, 2000
Review: 176 days
Class: Class II
Product code: MNH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K990745 (1999). 912 later devices descend from it, 21 citing it directly. 2 of the 914 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
This deviceK992739 Click'xSynthes Spine · 2000
Descendant · cites it directly · 774 of its ownK052123 Synthes Pangea SystemSynthes (Usa) · 2005
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

Showing 5 of 912 descendants. See all descendants

Descendants cleared per year

2004high 87 (2023) · low 2 (2004)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix Systemcites it directly · 2010
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 912 · See all

K052123Synthes Pangea SystemSynthes (Usa) · 2005 · cites it directly774descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
0 (this device)	K992739	Click'x	Synthes Spine	2000	—
+1	K052123	Synthes Pangea System	Synthes (Usa)	2005	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	3	0
2007	3	0
2008	10	0
2009	12	0
2010	15	1
2011	19	0
2012	35	0
2013	42	0
2014	46	0
2015	57	0
2016	49	0
2017	57	0
2018	58	0
2019	45	0
2020	57	0
2021	44	1
2022	61	0
2023	87	0
2024	77	0
2025	64	0
2026	67	0

FIG. 1 — Lineage of K992739, 1999–2026Source: 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

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
*	K990745	Modification to Synthes Universal Spinal System Summary page 1 …pinal system Synthes USS are currently marketed in the U.S. The indications for use, warnings and precautions for the subject components are similar to those cleared via K990745 and conform to labeling requirements set forth by 21 CFR 888.3070and FR Notice published 7/27/98 [Docket No. 95N-0176]. Posterio…	Synthes Spine	1999	—

Also cleared against K990745: 2 other devices →

What descends from it? (912)

See all 912

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

Number	Device	Applicant	Decided	Descendants
K052123	Synthes Pangea System	Synthes (Usa)	2005	774
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
K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	348
K100952	Modification to Synthes Matrix System Class I	Synthes Spine	2010	314
K111358	Synthes Uss	Synthes Spine	2011	151
K113149	Synthes Uss Connectors	Synthes Spine	2012	93
K113044	Synthes Mirs	Synthes Spine	2011	93

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2013	Class II	Z-0938-2013	Employee error	Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.

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 · Cites it directly · ◆ 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?

Its one ancestor has no recall.
Of its descendants, K052123 (Synthes (Usa), 2005) has gone furthest, with 774 descendants of its own.
2 other devices also cite its predicate K990745.

How does its category compare?

All MNH devices

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

FDA decisions per year · MNH

8in 2016

2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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	5	123	0	18
2008	13	65	0	30
2009	13	151	7	45
2010	10	106	0	59
2011	17	171	0	107
2012	7	93	1	433
2013	10	124	1	464
2014	12	140	0	286
2015	10	99	0	152
2016	8	93	1	216
2017	0	—	0	174
2018	0	—	0	129
2019	0	—	0	403
2020	0	—	0	432
2021	0	—	0	531
2022	0	—	0	265
2023	0	—	0	121
2024	0	—	0	302
2025	0	—	0	89
2026	0	—	0	—

What is it indicated for?

Posterior Components When used as a posterior pedicle screw fixation system, the Synthes USS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation…

Read the full statement (377 words)

Posterior Components

When used as a posterior pedicle screw fixation system, the Synthes USS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes USS is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature 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 for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system, the Synthes USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann’s disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

The Click’X components of the Synthes USS, when used as a posterior pedicle screw fixation system, are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal tumor and failed previous fusion (pseudoarthrosis).

In addition, the Click’X components of the Synthes USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature 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 for these patients are L3-§2.

In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System.

Anterior Components

The Anterior Components of the USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-LS5).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992739 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992739: Click'x.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992739

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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