510(k) Report

510(k) · Cleared

Cleared

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

K251441510(k) TraditionalCleared Nov 7, 2025182-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

Inion OY · JEY Plate, Bone

Cleared on Nov 7, 2025 as substantially equivalent to K010352 (Inion, Ltd., 2001) and 6 other predicates after a 182-day review. Its family tree reaches back 2 generations to 2001.

Decided
Nov 7, 2025
Review
182 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K010352 (2001). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestorReference device: K251472 · Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System · Inion OY · 2025Reference device: K062789 · Synthes (Usa) Rapid Resorbable Fixation System · Synthes (Usa) · 2007 · recalledReference device: K992158 · Lactosorb Sheets · Biomet, Inc. · 1999K010352 · CPS 1.5/2.0/2.5 Bioabsorbable Fixation System · Inion, Ltd. · 2001 · recalledK013039 · Inion CPS 2.0 Orthognathic Plate · Inion, Ltd. · 2001200020052010201520202025
Other ancestors, by generation 1 generation back: 5 other ancestors K013039 · Inion CPS 2.0 Orthognathic Plate · Inion, Ltd. · 2001K010352 · CPS 1.5/2.0/2.5 Bioabsorbable Fixation System · Inion, Ltd. · 2001 · recalled0
  1. Root · 2 generations backK010352 CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion, Ltd. · 2001 · Recalled
  2. 1 generation backK013039 Inion CPS 2.0 Orthognathic PlateInion, Ltd. · 2001
  3. This deviceK251441 Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS…Inion OY · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010352CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion, Ltd.20013
−1K013039Inion CPS 2.0 Orthognathic PlateInion, Ltd.2001—
0 (this device)K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5…Inion OY2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200310
201310
FIG. 1 — Lineage of K251441, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010352CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
Summary page 5
…em Predicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010352, K122890, K013039, K022981, K020266 Predicate Device Classification & Name…
Inion, Ltd.20013
*K122890Inion CPS Orbital Plates
Summary page 5
…redicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010352, K122890, K013039, K022981, K020266 Predicate Device Classification & Name 872.…
Inion OY2013—
*K013039Inion CPS 2.0 Orthognathic Plate
Summary page 5
…Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010352, K122890, K013039, K022981, K020266 Predicate Device Classification & Name 872.4760 Plat…
Inion, Ltd.2001—
*K022981Inion CPS 2.5/2.8 Screw
Summary page 5
…nufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010352, K122890, K013039, K022981, K020266 Predicate Device Classification & Name 872.4760 Plate, Bone…
Inion, Ltd.2002—
*K020266Inion CPS Bsso Screw
Summary page 5
…mmon Name: Bone Plate Predicate Device Premarket Notification # K010352, K122890, K013039, K022981, K020266 Predicate Device Classification & Name 872.4760 Plate, Bone 872.4880 S…
Inion, Ltd.20023
*K010351Inion CPS Baby 1.5 Bioabsorbable Fixation System
Summary page 5
…em Predicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010351, K033194 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification & C…
Inion, Ltd.20012
*K033194Inion CPS Baby 1.5 Bioabsorbable System
Summary page 5
…redicate Device Manufacturer: Inion Oy Predicate Device Common Name: Bone Plate Predicate Device Premarket Notification # K010351, K033194 Predicate Device Classification & Name 872.4760 Plate, Bone Predicate Device Classification & Class II 5…
Inion, Ltd.2003—
†K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…Inion OY2025—
†K062789Synthes (Usa) Rapid Resorbable Fixation SystemSynthes (Usa)20073
†K992158Lactosorb SheetsBiomet, Inc.1999—

Also cleared against K010352: 8 other devices →

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?

  • The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 24.1 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K010352.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
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

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures in the mid-face and maxilla of infant (from 29 days to 2 years of age) and child (greater than 2 years to 12 years of age) patients. Specific indications: - congenital anomalies correction in the orbital rim, orbital floor, maxilla and midface - traumatic injuries. The INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM implants…

Read the full statement (150 words)

The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures in the mid-face and maxilla of infant (from 29 days to 2 years of age) and child (greater than 2 years to 12 years of age) patients.

Specific indications:

- congenital anomalies correction in the orbital rim, orbital floor, maxilla and midface

- traumatic injuries.

The INION CPS™ 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM implants are intended for use in trauma and reconstructive procedures, and to maintain the relative position of bone grafts or bone graft substitutes, in orbital floor, medial and lateral orbital walls, orbital rim, mid-face, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) of child (greater than 2 years to 12 years of age), adolescent (greater than 12 years through 21 years of age) and adult patients. Specific indications: fixation of LeFort (I, II, III) osteotomies and mandibular orthognathic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K010352

8 other devices cite the same predicate.

  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K122890Inion CPS Orbital PlatesInion OY · 2013
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  • K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
  • K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007
  • K022981Inion CPS 2.5/2.8 ScrewInion, Ltd. · 2002

More from Inion OY

14 FDA decisions under this applicant name. See the company

  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K203105Inion CompressOn ScrewInion OY · 2021
  • K191764Inion BioRestoreInion OY · 2019
  • K151360Inion Spinal Graft Containment SystemInion OY · 2015
  • K133932Inion FreedompinInion OY · 2014

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024

https://510kreport.com/device/K251441 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251441: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251441

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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