510(k) · Cleared
ClearedInion Otps Biodegradable Mesh Plating System
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 Mar 1, 2004 as substantially equivalent to K021164 (Macropore Biosurgery, Inc., 2002) and 2 other predicates after a 250-day review. Its family tree reaches back 2 generations to 1998. 21 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 250 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974017 (1998). 4 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 1 generation backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- This deviceK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
- Descendant · cites it directly · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
- Descendant · 2 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
- Descendant · 2 generations on · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022
- Descendant · 3 generations on · 4 of its ownK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · cites it directly17descendants
- K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 2 generations on8descendants
- K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · 2 generations on6descendants
- K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 3 generations on4descendants
- K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −1 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| 0 (this device) | K031961 | Inion Otps Biodegradable Mesh Plating System | Inion, Ltd. | 2004 | — |
| +1 | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) | Inion OY | 2013 | — |
| +2 | K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016 | — |
| +2 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| +3 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO, Ltd. | 2022 | — |
| +3 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K021164 | Macropore OS TraumaSummary page 1…FICATION AND PRODUCT CODE Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3030, 87 HRS (plate) PREDICATE DEVICES (1) MacroPore OS Trauma System (K021164) (2) MacroPoreOS Protective Sheet (K994158) (3) Synthes Resorbable Meshes and Sheets (K003788)… | 2002 |
| * | K994158 | Macrosorbos Protective SheetSummary page 1…nel: Orthopedic Regulatory Class: Class II 21 CFR 888.3030, 87 HRS (plate) PREDICATE DEVICES (1) MacroPore OS Trauma System (K021164) (2) MacroPoreOS Protective Sheet (K994158) (3) Synthes Resorbable Meshes and Sheets (K003788) Date: 18.6.… | 2000 |
| * | K003788 | Synthes Resorable Meshes and SheetsSummary page 1…88.3030, 87 HRS (plate) PREDICATE DEVICES (1) MacroPore OS Trauma System (K021164) (2) MacroPoreOS Protective Sheet (K994158) (3) Synthes Resorbable Meshes and Sheets (K003788) Date: 18.6.2003… | 2001 |
What descends from it? (21)
See all 212 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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123672 (Inion OY, 2013) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K021164.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Inion OTP)IM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Inion OTPSIM Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Inion OTPSIM Biodegradable Mesh Plating System is intended…
Read the full statement (148 words)
Inion OTP)IM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Inion OTPSIM Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Inion OTPSIM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following:
• Long bones
• Flat bones
• Short bones
• Irregular bones
• Appendicular skeleton
• Thorax
When used alone (without traditional rigid fixation), the Inion OTPSI Biodegradable Mesh Plating System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving:
• Tumor resections where bone strength has not been compromised.
• Iliac crest harvest sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031961: Inion Otps Biodegradable Mesh Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031961
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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