510(k) · Cleared
ClearedInion Otps Biodegradable Mini Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion, Ltd. · HWC Screw, Fixation, Bone
Cleared on May 30, 2003 as substantially equivalent to K992301 (Biomet Manufacturing, Inc., 1999) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- May 30, 2003
- Review
- 190 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991763 (1999). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991763 Lactosorb Hand SystemBiomet, Inc. · 1999
- This deviceK023887 Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008
- Descendant · 3 generations on · 0 of its ownK120163 Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
- Descendant · cites it directly · 0 of its ownK050388 Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
Most influential descendants
Showing 4 of 4 · See all- K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007 · cites it directly2descendants
- K081588RE-Zorb Plating SystemAcute Innovations, LLC · 2008 · 2 generations on1descendant
- K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012 · 3 generations on0descendants
- K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991763 | Lactosorb Hand System | Biomet, Inc. | 1999 | — |
| 0 (this device) | K023887 | Inion Otps Biodegradable Mini Plating System | Inion, Ltd. | 2003 | — |
| +1 | K063410 | Inion CPS/Otps Freedomplate | Inion, Ltd. | 2007 | — |
| +2 | K081588 | RE-Zorb Plating System | Acute Innovations, LLC | 2008 | — |
| +3 | K120163 | Acute Innovations Biobridge Resorbable Plating System | Acute Innovations, LLC | 2012 | — |
| +1 | K050388 | Refix Internal Fracture Fixation Screws | Xtremi-T, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K992301 | Reunite ScrewsSummary page 1…w) 21 CFX 888.3030 - Single multiple component metallic bone fixation appliances and accessories, 87 HRS (plate) PREDICATE DEVICES (1) Biomet Inc.; Reunite Bone Screw (K992301) (2) Biomet Inc.; Lactosorb Hand System (K991763) (3) Syntehes(USA); Synthes Compact Hand 1.0/1.3 (pre-amendment device) === Pag… | 1999 |
| * | K991763 | Lactosorb Hand SystemSummary page 1…tallic bone fixation appliances and accessories, 87 HRS (plate) PREDICATE DEVICES (1) Biomet Inc.; Reunite Bone Screw (K992301) (2) Biomet Inc.; Lactosorb Hand System (K991763) (3) Syntehes(USA); Synthes Compact Hand 1.0/1.3 (pre-amendment device) DEVICE DESCRIPTION AND PRINCIPLES OF OPER… | 1999 |
| * | — | Synthes Compact Hand 1.0/1.3 Named without a submission number |
What descends from it? (4)
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 HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Inion OTPSTMBiodegradable Mini Plating System is intended for use in fixation of non-comminuted diaphyseal fractures of the metacarpal, proximal phalangeal, middle phalangeal and osteotomies in the presence of appropriate immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023887: Inion Otps Biodegradable Mini Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023887
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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