510(k) · Cleared

Cleared

Uss Iliosacral, Uss Polyaxial

K082572510(k) TraditionalCleared Nov 24, 200880-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 Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Nov 24, 2008 as substantially equivalent to K010658 (Synthes (Usa), 2001) and 7 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1999. 2 of the 669 devices in its family, counting itself, have a Class I recall. 659 later devices descend from it.

Decided: Nov 24, 2008
Review: 80 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K990745 (1999). 9 ancestors in all, the oldest K963045 (1997). 659 later devices descend from it, 22 citing it directly. 2 of the 669 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
2 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
1 generation backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
This deviceK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
Descendant · cites it directly · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
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 · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011

Showing 5 of 659 descendants. See all descendants

Descendants cleared per year

2010high 67 (2023) · low 6 (2010)2026

Class I recalls in this family

K100952 Modification to Synthes Matrix Systemcites it directly · 2010
K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 659 · See all

K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly581descendants
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
K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 2 generations on269descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
−2	K992739	Click'x	Synthes Spine	2000	1
−1	K052123	Synthes Pangea System	Synthes (Usa)	2005	—
0 (this device)	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
+1	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
+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	K110070	TSRH Spinal System	Medtronic Sofamor Danck USA, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0
2001	2	0
2003	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K082572, 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.

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? (8)

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
*	K010658	Modified Uss Fracture System Summary page 1 …Orthopaedic and Rehabilitation Devices Panel ___________Product Code: NKB, MNH, MN!, KWQ, KWP Predicates: Synthes USS Fracture (K01 065 8) Synthes Universal Sacral System (K963045) Synthes USS VAS (K0025 17)…	Synthes (Usa)	2001	—
*	K963045	Synthes (U.S.a.) Universal Sacral System Summary page 1 …uct Code: NKB, MNH, MN!, KWQ, KWP Predicates: Synthes USS Fracture (K01 065 8) Synthes Universal Sacral System (K963045) Synthes USS VAS (K0025 17) Synthes Click'X (K992739, K03 1175)…	Synthes (Usa)	1997	—
*	K002517	Uss Vas Summary page 1 …cates: Synthes USS Fracture (K01 065 8) Synthes Universal Sacral System (K963045) Synthes USS VAS (K0025 17) Synthes Click'X (K992739, K03 1175) Synthes Pangea (K052 123)…	Synthes (Usa)	2000	—
*	K992739	Click'x Summary page 1 …Synthes Universal Sacral System (K963045) Synthes USS VAS (K0025 17) Synthes Click'X (K992739, K03 1175) Synthes Pangea (K052 123) Synthes USS (KO10108, K022949)…	Synthes Spine	2000	1
*	K031175	Click'x Monoaxial Screws and Hooks Summary page 1 …Synthes Universal Sacral System (K963045) Synthes USS VAS (K0025 17) Synthes Click'X (K992739, K03 1175) Synthes Pangea (K052 123) Synthes USS (KO10108, K022949) Device…	Synthes (Usa)	2003	—
*	K052123	Synthes Pangea System Summary page 1 …45) Synthes USS VAS (K0025 17) Synthes Click'X (K992739, K03 1175) Synthes Pangea (K052 123) Synthes USS (KO10108, K022949) Device The Synthes UISS Polyaxial and Synthes…	Synthes (Usa)	2005	—
*	K010108	Uss-Line Extension	Synthes	2001	—
*	K022949	Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss Summary page 1 …Synthes Click'X (K992739, K03 1175) Synthes Pangea (K052 123) Synthes USS (KO10108, K022949) Device The Synthes UISS Polyaxial and Synthes USS Iliosacral Systems are additions to Description:…	Synthes (Usa)	2003	—

Also cleared against K010658: 4 other devices →

What descends from it? (659)

See all 659

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

Number	Device	Applicant	Decided	Descendants
K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	581
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
K122226	Revere Stabilization System	Globus Medical, Inc.	2012	225
K111358	Synthes Uss	Synthes Spine	2011	151
K120291	OP Spine System	OrthoPediatrics Corp.	2012	138
K121630	Range Spinal System	K2m, Inc.	2012	127
K100044	Firebird Spinal Fixation System, Firebird Side-Loading Body	Blackstone	2010	117
K120270	Venus Spinal Fixation System	L&K BIOMED Co., Ltd.	2012	111

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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K091445 (Medtronic Sofamor Danek, 2010) has gone furthest, with 581 descendants of its own.
4 other devices also cite its predicate K010658.

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. 2008, 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 (307 words)

The Synthes USS (including 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, and USS l1iosacral) 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, and USS Iliosacral) can be linked to the CerviFix System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. 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, and USS Iliosacral).

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, and USS Iliosacral) 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/K082572 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082572: Uss Iliosacral, Uss Polyaxial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082572

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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