510(k) · Cleared

Cleared

AXIS 5.5 Lumbar Pedicle Screw System

K180301510(k) TraditionalCleared Apr 10, 201867-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

Axis Orthopaedics · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 10, 2018 as substantially equivalent to K042167 (Medtronic Sofamor Danek, 2004) after a 67-day review. Its family tree reaches back 3 generations to 2001.

Decided: Apr 10, 2018
Review: 67 days
Class: Class II
Product code: NKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K011508 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK011508 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
2 generations backK041460 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2004
1 generation backK042167 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
This deviceK180301 AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K011508	CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2001	—
−2	K041460	CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2004	—
−1	K042167	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
0 (this device)	K180301	AXIS 5.5 Lumbar Pedicle Screw System	Axis Orthopaedics	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K180301, 2001–2018Source: 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? (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
*	K042167	Modification to: CD Horizon Spinal System Summary page 5 …subject device is substantially equivalent with respect to its mechanical performance. Legally Marketed Predicate Devices: Primary: Medtronic CD Horizon Spinal System (K042167) Predicate Indications for Use: Primary: Medtronic (K042167)- The CD HORIZON® Spinal System is intended for posterior, non-cervic…	Medtronic Sofamor Danek	2004	—

Also cleared against K042167: 2 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 3.1 years on median.
1 of the 4 ancestors has a recall of any class.
2 other devices also cite its predicate K042167.

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. 2018, 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 AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K180301 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180301: AXIS 5.5 Lumbar Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180301

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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