510(k) · Cleared

Cleared

Synthes (U.S.a.) Universal Sacral System

K963045510(k) TraditionalCleared Feb 13, 1997192-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) · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 13, 1997 after a 192-day review. The FDA summary names its predicate without a number. 2 of the 663 devices in its family, counting itself, have a Class I recall. 662 later devices descend from it.

Decided: Feb 13, 1997
Review: 192 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 0

662 later devices descend from it, 11 citing it directly. 2 of the 663 devices in this family, counting this one, have a Class I recall.

This deviceK963045 Synthes (U.S.a.) Universal Sacral SystemSynthes (Usa) · 1997
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 · 350 of its ownK082914 ClampfixSynthes Spine · 2008
Descendant · cites it directly · 349 of its ownK090605 ClampfixSynthes (Usa) · 2009
Descendant · cites it directly · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011

Showing 5 of 662 descendants. See all descendants

Descendants cleared per year

2008high 67 (2023) · low 1 (2009)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 662 · See all

K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · cites it directly659descendants
K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
K082914ClampfixSynthes Spine · 2008 · cites it directly350descendants
K090605ClampfixSynthes (Usa) · 2009 · cites it directly349descendants
K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · cites it directly348descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963045	Synthes (U.S.a.) Universal Sacral System	Synthes (Usa)	1997	—
+1	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
+2	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
+1	K082914	Clampfix	Synthes Spine	2008	—
+1	K090605	Clampfix	Synthes (Usa)	2009	—
+1	K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	6	1
2011	7	0
2012	21	0
2013	29	0
2014	35	0
2015	45	0
2016	38	0
2017	47	0
2018	47	0
2019	34	0
2020	41	0
2021	32	1
2022	43	0
2023	67	0
2024	65	0
2025	52	0
2026	50	0

FIG. 1 — Lineage of K963045, 1997–2026Source: 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? (2)

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
*	—	SYNTHES (U.S.A.) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System… Named without a submission number			—
*	—	Texas Scottish Rite Hospital (TSRH) Variable Angle Screw Named without a submission number			—

What descends from it? (662)

See all 662

11 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
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
K100634	Synthes Matrix System	Synthes (Usa)	2010	316
K100952	Modification to Synthes Matrix System Class I	Synthes Spine	2010	314
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

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

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?

When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a…

Read the full statement (127 words)

When used as a posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann’s disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2).

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/K963045 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963045: Synthes (U.S.a.) Universal Sacral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963045

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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