510(k) · Cleared

Cleared

Romeo 2 Pad Posterior Axial Device

K141508510(k) TraditionalCleared Aug 21, 201476-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spineart · PEK Spinous Process Plate

Cleared on Aug 21, 2014 as substantially equivalent to K102195 (Globus Medical, Inc., 2011) and 7 other predicates after a 76-day review. Its family tree reaches back 7 generations to 1999. 1 later device descends from it.

Decided: Aug 21, 2014
Review: 76 days
Class: Class II
Product code: PEK
Recalls: None
Predicates: 8

Its longest line of descent runs back 7 generations to K990745 (1999). 32 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
5 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
4 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
3 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
2 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
1 generation backK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
This deviceK141508 Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
Descendant · cites it directly · 0 of its ownK161016 Z-Clamp ISP SystemZavation, LLC · 2016

Most influential descendants

Showing 1 of 1 · See all

K161016Z-Clamp ISP SystemZavation, LLC · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K990745	Modification to Synthes Universal Spinal System	Synthes Spine	1999	—
−6	K992739	Click'x	Synthes Spine	2000	1
−5	K052123	Synthes Pangea System	Synthes (Usa)	2005	—
−4	K082572	Uss Iliosacral, Uss Polyaxial	Synthes Spine	2008	—
−3	K091445	CD Horizon Spinal System	Medtronic Sofamor Danek	2010	—
−2	K101471	Axle Interspinous Fusion System	X-Spine Systems, Inc.	2010	1
−1	K130438	Axle Interspinous Fusion System	X-Spine Systems, Inc.	2013	1
0 (this device)	K141508	Romeo 2 Pad Posterior Axial Device	Spineart	2014	—
+1	K161016	Z-Clamp ISP System	Zavation, LLC	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1996	2	0
1997	1	0
1998	1	0
2000	3	0
2001	3	0
2003	3	0
2004	1	0
2005	2	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K141508, 1999–2016Source: 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 PEK? 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 PEK device

#1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 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? (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
*	K102195	SP-Fix Spinous Process Fixation Plate Summary page 4 …II Product Code PEK CFR section 888.3050 Device panel Orthopedic SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine (K112592, K130438); Spinous Process Fusion Plate by Lanx Legally marketed…	Globus Medical, Inc.	2011	—
*	K112592	Axle Peek Interspinous Fusion System Summary page 4 …888.3050 Device panel Orthopedic SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine (K112592, K130438); Spinous Process Fusion Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Proc…	X-Spine Systems, Inc.	2011	—
*	K130438	Axle Interspinous Fusion System Summary page 4 …888.3050 Device panel Orthopedic SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine (K112592, K130438); Spinous Process Fusion Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Process Plate…	X-Spine Systems, Inc.	2013	1
*	K071877	Lanx Spinal Fixation System Summary page 4 …s Medical (K102195); Axle® System by X-Spine (K112592, K130438); Spinous Process Fusion Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Process Plate by NuVasive predicate devices (K073278, K131238) and Spire® Spin…	Lanx, LLC	2007	—
*	K092536	Spinal Fixation System Summary page 4 …(K102195); Axle® System by X-Spine (K112592, K130438); Spinous Process Fusion Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Process Plate by NuVasive predicate devices (K073278, K131238) and Spire® Spinous Proce…	Lanx, Inc.	2009	—
*	K073278	Spinous Process Plate System Summary page 4 …s Fusion Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Process Plate by NuVasive predicate devices (K073278, K131238) and Spire® Spinous Process Plate by Medtronic (K032037). The ROMEO®2…	Nuvasive, Inc.	2008	—
*	K131238	Affix Spinous Process Plate System Summary page 4 …Plate by Lanx Legally marketed (K071877, K092536); Affix® spinous Process Plate by NuVasive predicate devices (K073278, K131238) and Spire® Spinous Process Plate by Medtronic (K032037). The ROMEO®2 PAD Poste…	Nuvasive, Inc.	2013	—
*	K032037	CD Horizon (Addition of Spinous Process Plate) Summary page 4 …® spinous Process Plate by NuVasive predicate devices (K073278, K131238) and Spire® Spinous Process Plate by Medtronic (K032037). The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplement…	Medtronic Sofamor Danek	2003	—

Also cleared against K102195: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161016	Z-Clamp ISP System	Zavation, LLC	2016	0

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 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
4 of the 32 ancestors have a recall of any class.
Of its descendants, K161016 (Zavation, LLC, 2016) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K102195.

How does its category compare?

All PEK devices

PEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · PEK

1in 2025

2007high 10 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PEK

60in 2023

2007high 176 (2016) · low 60 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PEK

1in 2021

2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PEK

3in 2025

2007high 17 (2021) · low 0 (2007)2025

MAUDE reports naming product code PEK, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	2
2012	0	—	0	0
2013	10	118	0	0
2014	8	120	0	2
2015	6	166	0	3
2016	4	176	0	0
2017	3	94	0	0
2018	4	69	0	2
2019	0	—	0	4
2020	2	—	0	2
2021	2	—	1	17
2022	3	135	0	11
2023	4	60	0	8
2024	1	—	0	5
2025	1	—	0	3
2026	1	—	0	—

What is it indicated for?

The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L.1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with 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) and /or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.

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/K141508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141508: Romeo 2 Pad Posterior Axial Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141508

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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