510(k) · Cleared

Cleared

Oria Claris

K023378510(k) TraditionalCleared Jun 27, 2003262-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

Ortho Tec, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 27, 2003 as substantially equivalent to K021679 (Ortho Tec, LLC, 2002) after a 262-day review. Its family tree reaches back 1 generation to 2002.

Decided: Jun 27, 2003
Review: 262 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K021679 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK021679 Oria Spinal Clip SystemOrtho Tec, LLC · 2002
This deviceK023378 Oria ClarisOrtho Tec, LLC · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021679	Oria Spinal Clip System	Ortho Tec, LLC	2002	—
0 (this device)	K023378	Oria Claris	Ortho Tec, LLC	2003	—

FIG. 1 — Lineage of K023378, 2002–2003Source: 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K021679	Oria Spinal Clip System Cleared while this submission was under review	Ortho Tec, LLC	2002	—

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?

Its one ancestor has no recall.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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	5	123	0	18
2008	13	65	0	30
2009	13	151	7	45
2010	10	106	0	59
2011	17	171	0	107
2012	7	93	1	433
2013	10	124	1	464
2014	12	140	0	286
2015	10	99	0	152
2016	8	93	1	216
2017	0	—	0	174
2018	0	—	0	129
2019	0	—	0	403
2020	0	—	0	432
2021	0	—	0	531
2022	0	—	0	265
2023	0	—	0	121
2024	0	—	0	302
2025	0	—	0	89
2026	0	—	0	—

What is it indicated for?

MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-SI joint; receiving fusions using autogenous bone graft only; having the device fixed or attached to the lumbar and sacral spine; and having the device removed after the development of a solid fusion mass. MNI - Posterior pedicle systems are intended to provide…

Read the full statement (131 words)

MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally

mature patients L3 & below who are:

having severe spondylolisthesis (Grades 3 and 4) at the L5-SI joint;

receiving fusions using autogenous bone graft only;

having the device fixed or attached to the lumbar and sacral spine; and

having the device removed after the development of a solid fusion mass.

MNI - Posterior pedicle systems are intended to provide immobilization and stabilization of

spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the

following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral

spine (T-10 - S1/2):

degenerative spondylolisthesis with objective evidence of neurologic impairment

fracture

dislocation

scoliosis

kyphosis

spinal tumor

failed previous fusion (pseudarthrosis)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023378 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023378: Oria Claris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023378

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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