510(k) · Cleared
ClearedInion CPS Baby 1.5 Bioabsorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · JEY Plate, Bone
Cleared on Sep 20, 2005 as substantially equivalent to K010351 (Inion, Ltd., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Sep 20, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982531 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK982531 Howmedica Leibinger Resorbable Fixation SystemHowmedica Corp. · 1998
- This deviceK052444 Inion CPS Baby 1.5 Bioabsorbable Fixation SystemInion, Ltd. · 2005
- 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 1 of 1 · See all- 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 | K982531 | Howmedica Leibinger Resorbable Fixation System | Howmedica Corp. | 1998 | — |
| 0 (this device) | K052444 | Inion CPS Baby 1.5 Bioabsorbable Fixation System | Inion, Ltd. | 2005 | — |
| +1 | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby… | Inion OY | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K010351 | Inion CPS Baby 1.5 Bioabsorbable Fixation SystemSummary page 1…SEP 2 0 2005 SPECIAL 510(k) SUMMARY for the line extension of INION CPS Tm Baby 1.5 Bioabsorbable Fixation System (K010351) MANUFACTURER Inion Ltd., Liiiikiirinkatu 2, FIN-33520 Tampere, FINLAND… | 2001 |
| * | K982531 | Howmedica Leibinger Resorbable Fixation SystemSummary page 1…Regulatory Class: Class II Product Code: JEY PREDICATE DEVICE Howmedica Leibinger Resorbable Fixation System (K98253 1) CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exis… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable… | 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?
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 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?
A. General indications: Tile INION CPS BABY 1.5 B1OABSORBABLE FIXATION SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
B. Specific indications:
•Fractures of the cranium, mid-face and maxilla
*Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
*LeFort (I, II, III) osteotomies
*Pediatric reconstructive procedures
*Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla
*Craniotomy flap fixation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052444: Inion CPS Baby 1.5 Bioabsorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052444
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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