510(k) · Cleared
ClearedInion CPS/Otps Freedomplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · HRS Plate, Fixation, Bone
Cleared on Jan 23, 2007 as substantially equivalent to K010352 (Inion, Ltd., 2001) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Jan 23, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K974017 (1998). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 2 generations backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- 1 generation backK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
- This deviceK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK120163 Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −2 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| −1 | K031961 | Inion Otps Biodegradable Mesh Plating System | Inion, Ltd. | 2004 | — |
| 0 (this device) | K063410 | Inion CPS/Otps Freedomplate | Inion, Ltd. | 2007 | — |
| +1 | K081588 | RE-Zorb Plating System | Acute Innovations, LLC | 2008 | — |
| +2 | K120163 | Acute Innovations Biobridge Resorbable Plating System | Acute Innovations, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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 |
|---|---|---|---|
| * | K010352 | CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | 2001 |
| * | K023887 | Inion Otps Biodegradable Mini Plating SystemSummary page 1…with the predicate devices finion® CPSTM 1.5/2.0/2.5 Bioabsorbable Fixation System (KG 10352), Inion®)OTPS'M Biodegradable Ylini Plating System (K023887) and Inion®0 OT'PS TM Biodegradable Mesh Plating System (K03 196 1). Inion CPS/OTPS FreedomPlate TM i… | 2003 |
| * | K031961 | Inion Otps Biodegradable Mesh Plating SystemSummary page 1…Fixation System (KG 10352), Inion®)OTPS'M Biodegradable Ylini Plating System (K023887) and Inion®0 OT'PS TM Biodegradable Mesh Plating System (K03 196 1). Inion CPS/OTPS FreedomPlate TM is subistantially equivalent to predicate Class II devices, when Use… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081588 | RE-Zorb Plating System | 2008 | 1 |
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 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K081588 (Acute Innovations, LLC, 2008) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K010352.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.
B. Specific indications:
1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
2. Metacarpus, proximal and middle phalangeal bones
3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063410 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063410: Inion CPS/Otps Freedomplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063410
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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