510(k) · Cleared

Cleared

Synthes Pangea Monoaxial System

K052151510(k) TraditionalCleared Dec 7, 2005121-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 Co.Lp · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 7, 2005 as substantially equivalent to K031175 (Synthes (Usa), 2003) after a 121-day review. Its family tree reaches back 1 generation to 2003. 2 of the 564 devices in its family, counting itself, have a Class I recall. 562 later devices descend from it.

Decided: Dec 7, 2005
Review: 121 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031175 (2003). 562 later devices descend from it, 7 citing it directly. 2 of the 564 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK031175 Click'x Monoaxial Screws and HooksSynthes (Usa) · 2003
This deviceK052151 Synthes Pangea Monoaxial SystemSynthes Spine Co.Lp · 2005
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 · 2 generations on · 314 of its ownK100952 Modification to Synthes Matrix SystemSynthes Spine · 2010 · Recalled (Class I)
Descendant · cites it directly · 277 of its ownK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
Descendant · 2 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012

Showing 5 of 562 descendants. See all descendants

Descendants cleared per year

2007high 57 (2023) · low 2 (2007)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 562 · 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 · 2 generations on314descendants
K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · cites it directly277descendants
K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on260descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031175	Click'x Monoaxial Screws and Hooks	Synthes (Usa)	2003	—
0 (this device)	K052151	Synthes Pangea Monoaxial System	Synthes Spine Co.Lp	2005	—
+1	K103287	Synthes 6.0 Cocr and CPT TI-3 Rods	Synthes Spine	2011	—
+1	K100634	Synthes Matrix System	Synthes (Usa)	2010	—
+2	K100952	Modification to Synthes Matrix System	Synthes Spine	2010	Class I
+1	K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	3
+2	K113395	Revere 4.5 Stabilization System	Globus Medical, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	7	0
2009	2	0
2010	10	1
2011	10	0
2012	17	0
2013	22	0
2014	18	0
2015	30	0
2016	26	0
2017	37	0
2018	36	0
2019	31	0
2020	37	0
2021	33	1
2022	37	0
2023	57	0
2024	56	0
2025	49	0
2026	45	0

FIG. 1 — Lineage of K052151, 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.

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

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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
*	K031175	Click'x Monoaxial Screws and Hooks Summary page 1 …oaxial System Device Description: The Pangearm Monoaxial Screws and Hooks are similar to the cleared SYNTHES Click'X Monoaxial System (K031 175). Both are components of the Universal Spinal System (USS). Pangea Monoaxi…	Synthes (Usa)	2003	—

Also cleared against K031175: 19 other devices →

What descends from it? (562)

See all 562

7 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
K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	277
K082797	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	209
K070973	Quantum Spinal System	Pioneer Surgical Technology	2007	178
K141044	M.U.S.T. Extension	Medacta International	2014	16
K133366	Orthros Posterior Stabilization System	Camber Spine	2014	2

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?

Its one ancestor has no recall.
Of its descendants, K103287 (Synthes Spine, 2011) has gone furthest, with 348 descendants of its own.
19 other devices also cite its predicate K031175.

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.

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 (284 words)

The Synthes USS (including the Click’X®, USS VAS variable axis components, and Pangea™), Click’ X® Monoaxial, Pangea Monoaxial, Dual-Opening and the Small Stature USS (which inctudes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-82), 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 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, pseudoarthrosis, and failed previous fusion.

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 the Click'X, USS VAS variable axis components, and Pangea), Click’X Monoaxial, Pangea Monoaxial, and Dual Opening USS 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 the Click'X, USS VAS variable axis components, and Pangea), the Click'X Monoaxial, Pangea Monoaxial, and Dual Opening USS Systems.

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

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/K052151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052151: Synthes Pangea Monoaxial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052151

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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