510(k) · Cleared
ClearedMacropore OS Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macropore Biosurgery, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 1, 2002 after an 81-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Jul 1, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK021164 Macropore OS TraumaMacropore Biosurgery, Inc. · 2002
- Descendant · cites it directly · 21 of its ownK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
- Descendant · 2 generations on · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
- Descendant · 3 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
- Descendant · 3 generations on · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- Descendant · 4 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004 · cites it directly21descendants
- K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · 2 generations on17descendants
- K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 3 generations on8descendants
- K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · 3 generations on6descendants
- K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021164 | Macropore OS Trauma | Macropore Biosurgery, Inc. | 2002 | — |
| +1 | K031961 | Inion Otps Biodegradable Mesh Plating System | Inion, Ltd. | 2004 | — |
| +2 | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) | Inion OY | 2013 | — |
| +3 | K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016 | — |
| +3 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| +4 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | — | MacroPore OS Protective Sheet Named without a submission number | |
| * | — | Synthes Resorbable Meshes and Sheets Named without a submission number | |
| * | — | MacroPore OS Spine Named without a submission number |
What descends from it? (26)
See all 262 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?
- Of its descendants, K031961 (Inion, Ltd., 2004) has gone furthest, with 21 descendants of its own.
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?
The MacroPore OS Trauma System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position weak bony tissue in…
Read the full statement (158 words)
The MacroPore OS Trauma System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position weak bony tissue in trauma and reconstructive orthopedic procedures involving:
Long bones
Flat bones
Short bones
Irregular bones
Appendicular skeleton
Thorax
When used alone (without traditional rigid fixation), the MacroPore OS Trauma System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:
Tumor resections where bone strength has not been compromised
Iliac crest harvests
Ribs
This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021164: Macropore OS Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021164
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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