510(k) · Cleared
ClearedInion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inion OY · HWC Screw, Fixation, Bone
Cleared on Feb 27, 2013 as substantially equivalent to K031961 (Inion, Ltd., 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1979. 17 later devices descend from it.
- Decided
- Feb 27, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K792022 (1979). 19 ancestors in all. 17 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 4 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 3 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 2 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 1 generation backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- This deviceK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
- Descendant · cites it directly · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
- Descendant · cites it directly · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022
- Descendant · 2 generations on · 4 of its ownK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · cites it directly8descendants
- K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · cites it directly6descendants
- K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 2 generations on4descendants
- K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021 · 2 generations on4descendants
- K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −4 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −3 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −2 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −1 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| 0 (this device) | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) | Inion OY | 2013 | — |
| +1 | K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016 | — |
| +1 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| +2 | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO, Ltd. | 2022 | — |
| +2 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
| +2 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®… | OSSIO, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K031961 | Inion Otps Biodegradable Mesh Plating SystemSummary page 1…Code: HWC Common name: Bone screw Regulation number: 888.3040 Predicate device K03 1961 K043 142 K030900 Conformance with performance No a… | 2004 |
| * | K043142 | Inion Otps Biodegradable Mini Plating SystemSummary page 1…Common name: Bone screw Regulation number: 888.3040 Predicate device K03 1961 K043 142 K030900 Conformance with performance No applicable mandatory performance standards exi… | 2005 |
| * | K030900 | Inion Otps Biodegradable Fixaton SystemSummary page 1…Regulation number: 888.3040 Predicate device K03 1961 K043 142 K030900 Conformance with performance No applicable mandatory performance standards exist for standards t… | 2003 |
What descends from it? (17)
See all 175 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 34 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K160304 (Phalanx Innovations, 2016) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K031961.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 FreedomScrewM products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomnies, arthrodeses or bone grafts (i.e., autografis or allografis) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace). In addition, the Inion FreedomScrewTM 03.5/4.0/4.5 mm products are specifically intended for use in following indications: A. General indications…
Read the full statement (98 words)
The Inion FreedomScrewM products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomnies, arthrodeses or bone grafts (i.e., autografis or allografis) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion FreedomScrewTM 03.5/4.0/4.5 mm products are specifically intended for use in following indications:
A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomnies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123672: Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123672
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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