510(k) · Cleared
ClearedInion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · JEY Plate, Bone
Cleared on May 27, 2005 as substantially equivalent to K010351 (Inion, Ltd., 2001) and 2 other predicates after a 4-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 4 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K971870 (1997). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971870 Lactosorb Trauma Plating SystemBiomet, Inc. · 1997
- This deviceK051341 Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole…Inion, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK070737 Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesProsurg, Inc. · 2007
- 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
- Descendant · 2 generations on · 0 of its ownK072528 Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation…Prosurg, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K070737Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesProsurg, Inc. · 2007 · cites it directly1descendant
- K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…Inion OY · 2025 · cites it directly0descendants
- K072528Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & AccessoriesProsurg, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971870 | Lactosorb Trauma Plating System | Biomet, Inc. | 1997 | — |
| 0 (this device) | K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates… | Inion, Ltd. | 2005 | — |
| +1 | K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories | Prosurg, Inc. | 2007 | — |
| +1 | K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby… | Inion OY | 2025 | — |
| +2 | K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System &… | Prosurg, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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? (3)
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…MAY 2 '72005 SPECIAL 510(k) SUMMARY for the line extension of INION CPS Tm Baby 1.5 Bioabsorbable Fixation System (K010351) MANUFACTURER Inion Ltd.. Liiik;irinkatu 2, FIN-33520 Tampere, FINLAND… | 2001 |
| * | K992355 | Lactosorb Trauma Plating SystemSummary page 1…egulatory Class: Class II Product Code: JEY PREDICATE DEVICE LactoSorb Trauma Plating System 1.5 38 hole plate (K992355, K971870) CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance stand… | 1999 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…Class: Class II Product Code: JEY PREDICATE DEVICE LactoSorb Trauma Plating System 1.5 38 hole plate (K992355, K971870) CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exis… | 1997 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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: The INION CPSTM I BABY 1.5 BIOABSORBABLE 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 (1,11, 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/K051341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051341
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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