510(k) · Cleared

Cleared

Inion CPS Baby 1.5 Bioabsorbable System

K033194510(k) SpecialCleared Oct 30, 200328-day reviewClass II21 CFR 872.4760

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

Cleared on Oct 30, 2003 as substantially equivalent to K010351 (Inion, Ltd., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: Oct 30, 2003
Review: 28 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010351 (2001). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010351 Inion CPS Baby 1.5 Bioabsorbable Fixation SystemInion, Ltd. · 2001 · Recalled
This deviceK033194 Inion CPS Baby 1.5 Bioabsorbable SystemInion, Ltd. · 2003
Descendant · cites it directly · 0 of its ownK251441 Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS…Inion OY · 2025
Descendant · cites it directly · 0 of its ownK251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5…Inion OY · 2025

Most influential descendants

Showing 2 of 2 · See all

K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…Inion OY · 2025 · cites it directly0descendants
K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…Inion OY · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010351	Inion CPS Baby 1.5 Bioabsorbable Fixation System	Inion, Ltd.	2001	2
0 (this device)	K033194	Inion CPS Baby 1.5 Bioabsorbable System	Inion, Ltd.	2003	—
+1	K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5…	Inion OY	2025	—
+1	K251472	Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby…	Inion OY	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	2	0

FIG. 1 — Lineage of K033194, 2001–2025Source: 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 JEY? 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 JEY device

#1 K252246 Leforte MMF Systemscore 15.6 · 16 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
*	K010351	Inion CPS Baby 1.5 Bioabsorbable Fixation System Summary page 1 …2.4760 bone plates are classified as Class 11. Bone plates have been assigned Product Code 76 JEY PREDICATE DEVICE Baby 1.5 Bioabsorbable Fixation System (K010351) (1) Inion CPSTM INTENDED USE Indications for use remain identical with the previously cleared Inion CPS'rblBaby…	Inion, Ltd.	2001	2

Also cleared against K010351: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…	Inion OY	2025	0
K251472	Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…	Inion OY	2025	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?

Its one ancestor has a recall.
Of its descendants, K251441 (Inion OY, 2025) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K010351.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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	9	115	0	29
2008	7	84	3	24
2009	4	121	6	93
2010	6	199	85	215
2011	5	75	0	241
2012	10	194	0	428
2013	8	126	1	766
2014	6	223	0	616
2015	7	160	0	767
2016	1	—	0	558
2017	5	190	0	568
2018	7	255	0	608
2019	6	163	0	595
2020	6	198	1	680
2021	4	299	0	451
2022	5	135	0	344
2023	2	—	0	495
2024	5	159	0	696
2025	2	—	0	1,003
2026	3	258	0	—

What is it indicated for?

Indications: A. General indications: The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla. B. Specific indications: Fractures of the cranium, midface and maxilla. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations). LeFort (I, 11, 111) osteotomies. Pediatric reconstructive procedures. Orthognathic or reconstructive…

Read the full statement (125 words)

Indications:

A. General indications: The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla.

B. Specific indications:

Fractures of the cranium, midface and maxilla.

Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).

LeFort (I, 11, 111) osteotomies.

Pediatric reconstructive procedures.

Orthognathic or reconstructive procedures of the cranium, midface or maxilla.

Craniotomy flap fixation.

Contraindications:

The Inion CPS Baby 1.5 Bioabsorbable Fixation System is not intended for use in and is contraindicated for:

1. Mandibular tumor resection.

2. Active or potential infection.

3. Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed. (e.g., alcoholism, drug abuse)

4. DO NOT USE in the mandible.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033194: Inion CPS Baby 1.5 Bioabsorbable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033194

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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