510(k) · Cleared

Cleared

Del Mar Monoaxial Pedicle Screw System

K110679510(k) SpecialCleared Aug 2, 2011145-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

Phygen, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Aug 2, 2011 as substantially equivalent to K091219 (Allez Spine, LLC, 2009) and 1 other predicate after a 145-day review. Its family tree reaches back 3 generations to 1999.

Decided: Aug 2, 2011
Review: 145 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K981676 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
2 generations backK050060 Laguna Pedicle Screw SystemAllez Spine, LLC · 2005 · Recalled
1 generation backK051275 Laguna Monoaxial Pedicle Screw SystemAllez Spine, LLC · 2005 · Recalled
This deviceK110679 Del Mar Monoaxial Pedicle Screw SystemPhygen, LLC · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K981676	CD Horizon Spinal System	Sofamor Danek USA,Inc.	1999	—
−2	K050060	Laguna Pedicle Screw System	Allez Spine, LLC	2005	27
−1	K051275	Laguna Monoaxial Pedicle Screw System	Allez Spine, LLC	2005	21
0 (this device)	K110679	Del Mar Monoaxial Pedicle Screw System	Phygen, LLC	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K110679, 1999–2011Source: 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.

Planning a device in NKB? 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? (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
*	K091219	Del Mar Monoaxial Pedicle Screw System Summary page 1 …r ASTM F1 058. Equivalence: The modified Del Mar® Pedicle Screw System is substantially equivalent to the Del Mar@ Pedicle Screw System (K091 219 S/E 7/9/2009 and unmodified K051275 S/E 12/9/2005, which is manufactured and marketed by Phygen,…	Allez Spine, LLC	2009	—
*	K051275	Laguna Monoaxial Pedicle Screw System Summary page 1 …Pedicle Screw System is substantially equivalent to the Del Mar@ Pedicle Screw System (K091 219 S/E 7/9/2009 and unmodified K051275 S/E 12/9/2005, which is manufactured and marketed by Phygen, LLC. 51 0(k) Summary for Del Mar® Ped…	Allez Spine, LLC	2005	21

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
2 of the 4 ancestors have a recall of any class.

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. 2011, 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?

The DEL MAR® Monoaxial Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions:

Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110679 · printed Nov 3, 2026

Cite this page

510(k) Report. “K110679: Del Mar Monoaxial Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110679

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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