510(k) Report

510(k) · Cleared

Recalled · 2010

CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

K010352510(k) TraditionalCleared Mar 14, 200136-day reviewClass II21 CFR 872.4760Recalls 3

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

Inion, Ltd. · JEY Plate, Bone

Cleared on Mar 14, 2001 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled 3 times.

Decided
Mar 14, 2001
Review
36 days
Class
Class II
Product code
JEY
Recalls
3
Predicates
0

13 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2001: 1 descendant cleared2002: 2 descendants cleared2013: 2 descendants cleared2025: 2 descendants cleared2008: 2 descendants cleared2010: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK010352 CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion, Ltd. · 2001
  2. Descendant · cites it directly · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
  3. Descendant · cites it directly · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  4. Descendant · cites it directly · 2 of its ownK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
  5. Descendant · cites it directly · 1 of its ownK122890 Inion CPS Orbital PlatesInion OY · 2013
  6. Descendant · 2 generations on · 1 of its ownK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22007: 22008: 22010: 12012: 12013: 22025: 2
2001high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all
  • K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · cites it directly3descendants
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · cites it directly2descendants
  • K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007 · cites it directly2descendants
  • K122890Inion CPS Orbital PlatesInion OY · 2013 · cites it directly1descendant
  • K081588RE-Zorb Plating SystemAcute Innovations, LLC · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010352CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion, Ltd.2001—
+1K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2007—
+1K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2008—
+1K063410Inion CPS/Otps FreedomplateInion, Ltd.2007—
+1K122890Inion CPS Orbital PlatesInion OY2013—
+2K081588RE-Zorb Plating SystemAcute Innovations, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200720
200820
201010
201210
201320
202520
FIG. 1 — Lineage of K010352, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073
K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082
K063410Inion CPS/Otps FreedomplateInion, Ltd.20072
K122890Inion CPS Orbital PlatesInion OY20131
K022981Inion CPS 2.5/2.8 ScrewInion, Ltd.20021
K020266Inion CPS Bsso ScrewInion, Ltd.20021
K013039Inion CPS 2.0 Orthognathic PlateInion, Ltd.20011
K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…Inion OY20250
K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…Inion OY20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 14, 2010Not classifiedZ-0630-2011OtherInadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
Apr 14, 2010Not classifiedZ-0631-2011OtherInadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
Mar 5, 2010Not classifiedZ-1550-2010Nonconforming Material/ComponentDuring a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061881 (Takiron Co., Ltd., 2007) has gone furthest, with 3 descendants of its own.

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

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—

More from Inion, Ltd.

23 FDA decisions under this applicant name. See the company

  • K071810Inion Spinal Graft Containment SystemInion, Ltd. · 2008
  • K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007
  • K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd. · 2006
  • K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2006
  • K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005

Recent decisions in JEY

The JEY category page

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  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K010352 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010352: 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 6, 2026. https://510kreport.com/device/K010352

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026