510(k) · Cleared

Cleared

Xenon (TM) Pedicle Screw System

K111634510(k) TraditionalCleared Jan 25, 2012226-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

Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 25, 2012 as substantially equivalent to K071890 (Alphatec Spine, Inc., 2007) and 2 other predicates after a 226-day review. Its family tree reaches back 9 generations to 1995.

Decided: Jan 25, 2012
Review: 226 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 3

Its longest line of descent runs back 9 generations to K950697 (1995). 66 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
5 generations between
3 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
2 generations backK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
1 generation backK110842 Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011
This deviceK111634 Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc. · 2012

Show all 9 generations

Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
5 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
4 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
3 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
2 generations backK092605 Xia 4.5 Spinal SystemStryker Spine · 2009
1 generation backK110842 Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011
This deviceK111634 Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K950697	Depuy Motech Moss Miami Spinal System - Pedicle Fixation	Depuy Motech	1995	—
−8	K050461	Xia 4.5 Spinal System	Stryker Spine	2005	—
−7	K052761	Modification to: Xia 4.5 Spinal System	Stryker Spine	2005	—
−6	K060361	Xia Spinal System, Xia 4.5 Spinal System	Stryker Spine	2006	1
−5	K060979	Xia Titanium and 4.5 Spinal Systems	Stryker Spine	2006	—
−4	K071373	Stryker Spine Xia Iii Spinal System	Stryker Spine	2007	1
−3	K083393	Xia 3 Spinal System	Stryker Spine	2009	1
−2	K092605	Xia 4.5 Spinal System	Stryker Spine	2009	—
−1	K110842	Atlas Spine Pedicle Screw System	Atlas Spine, Inc.	2011	—
0 (this device)	K111634	Xenon (TM) Pedicle Screw System	Alphatec Spine, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	3	0
1996	4	0
1997	2	0
1998	4	0
1999	3	0
2000	6	0
2001	5	0
2002	3	0
2003	7	0
2004	7	0
2005	4	0
2006	4	0
2007	2	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K111634, 1995–2012Source: 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? (3)

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
*	K071890	Zodiac 4.0 Polyaxial Spinal Fixation System Summary page 2 …oprietary/,Model Name Manufacturer 5 10(k) No. Zodiac' 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K100685 Apelo ,Pedicle Screw System…	Alphatec Spine, Inc.	2007	1
*	K100685	Zodiac Polyaxial Spinal Fixation System Summary page 2 …ac' 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K100685 Apelo ,Pedicle Screw System Atlas Spine, Inc. KI 110842 Performance Data: Mechanical static…	Alphatec Spine, Inc.	2010	—
*	K110842	Atlas Spine Pedicle Screw System Cleared while this submission was under review Summary page 2 …Polyaxial Spinal Fixation System Alphatec Spine, Inc. K100685 Apelo ,Pedicle Screw System Atlas Spine, Inc. KI 110842 Performance Data: Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiv…	Atlas Spine, Inc.	2011	—

Also cleared against K071890: 10 other devices →

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 17 years and passes through 4 companies; a new generation was cleared every 8 months on median.
11 of the 66 ancestors have a recall of any class.
10 other devices also cite its predicate K071890.

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. 2012, 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 XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in

skeletally mature patients as an adjunct to fusion for the following indications: 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. It is intended to provide stabilization during the development of fusion utilizing

autograft or allograft bone graft.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111634 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111634: Xenon (TM) Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111634

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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