510(k) · Cleared

Recalled · 2011

Synthes Matrix System

K092929510(k) TraditionalCleared Dec 29, 200997-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 (Usa) · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 29, 2009 after a 97-day review. The FDA summary names no predicate by number. 2 of the 399 devices in its family, counting itself, have a Class I recall. 398 later devices descend from it. It has been recalled once.

Decided: Dec 29, 2009
Review: 97 days
Class: Class II
Product code: NKB
Recalls: 1
Predicates: 0

398 later devices descend from it, 12 citing it directly. 2 of the 399 devices in this family, counting this one, have a Class I recall.

This deviceK092929 Synthes Matrix SystemSynthes (Usa) · 2009
Descendant · cites it directly · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
Descendant · cites it directly · 316 of its ownK100634 Synthes Matrix SystemSynthes (Usa) · 2010
Descendant · cites it directly · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
Descendant · 3 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012

Showing 5 of 398 descendants. See all descendants

Descendants cleared per year

2010high 50 (2024) · low 2 (2010)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 398 · See all

K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · cites it directly348descendants
K100634Synthes Matrix SystemSynthes (Usa) · 2010 · cites it directly316descendants
K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · cites it directly314descendants
K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants
K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on225descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K092929	Synthes Matrix System	Synthes (Usa)	2009	—
+1	K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	—
+1	K100634	Synthes Matrix System	Synthes (Usa)	2010	—
+1	K100952	Modification to Synthes Matrix System	Synthes Spine	2010	Class I
+2	K113395	Revere 4.5 Stabilization System	Globus Medical, Inc.	2012	—
+3	K122226	Revere Stabilization System	Globus Medical, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	1
2011	3	0
2012	12	0
2013	8	0
2014	13	0
2015	17	0
2016	14	0
2017	28	0
2018	25	0
2019	21	0
2020	28	0
2021	21	1
2022	28	0
2023	47	0
2024	50	0
2025	42	0
2026	39	0

FIG. 1 — Lineage of K092929, 2009–2026Source: 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.

Top candidate predicates for a new NKB device

#1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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?

The FDA summary names no predicate by number.

What descends from it? (398)

See all 398

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

Number	Device	Applicant	Decided	Descendants
K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	348
K100634	Synthes Matrix System	Synthes (Usa)	2010	316
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
K120571	Synthes Uss Connector	Synthes Spine	2012	74
K120838	Synthes Matrix System	Synthes Spine	2012	16
K121670	Medyssey Cannulated Pedicle Screw	Medyssey Co, Ltd.	2013	11
K123134	Easyspine System	Ldr Spine USA, Inc.	2013	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 11, 2011	Not classified	Z-3207-2011	Labeling Change Control	Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant…

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?

Of its descendants, K103287 (Synthes Spine, 2011) has gone furthest, with 348 descendants of its own.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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	38	87	4	34
2008	36	59	5	82
2009	44	71	33	171
2010	37	111	4	462
2011	48	84	3	577
2012	60	79	13	1,747
2013	35	73	0	1,962
2014	46	90	3 (1)	1,671
2015	55	90	3	1,446
2016	50	84	1	1,585
2017	63	69	1	1,618
2018	56	61	3	1,684
2019	39	84	1	1,915
2020	48	68	1	2,076
2021	32	61	0	1,745
2022	34	88	5	1,339
2023	44	72	2	919
2024	39	57	3	1,614
2025	24	61	1	1,171
2026	30	91	3	—

What is it indicated for?

Read the full statement (326 words)

The Synthes USS (including Matrix, USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

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

When used with the 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix).

In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) can be interchanged with all USS 6.0 mm rods and transconnectors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092929 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092929: Synthes Matrix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092929

Report an extraction error

Are you the manufacturer?

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