510(k) · Cleared
ClearedOSSIOfiber® Threaded Trimmable Fixation Nails
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OSSIO, Ltd. · HWC Screw, Fixation, Bone
Cleared on Mar 8, 2024 as substantially equivalent to K123672 (Inion OY, 2013) and 4 other predicates after a 162-day review. Its family tree reaches back 15 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 8, 2024
- Review
- 162 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K962616 (1996). 127 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- 2 generations backK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- 1 generation backK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- This deviceK233198 OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK241277 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK254077 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 5 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 4 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 3 generations backK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- 2 generations backK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- 1 generation backK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- This deviceK233198 OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −5 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −4 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| −3 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| −2 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
| −1 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®… | OSSIO, Ltd. | 2023 | — |
| 0 (this device) | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO, Ltd. | 2024 | — |
| +1 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2024 | — |
| +2 | K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Summary page 4…on Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Devices Inion FreedomScrew TM (K123672) - Primary Predicate OSSIOfiber® Compression Screw (K193660, K213596, K221193, K231272) - Additional Predicate Reference Devices… | 2013 |
| * | K193660 | OSSIOfiber™ Compression ScrewsSummary page 4…Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Devices Inion FreedomScrew TM (K123672) - Primary Predicate OSSIOfiber® Compression Screw (K193660, K213596, K221193, K231272) - Additional Predicate Reference Devices OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465, K23… | 2020 |
| * | K213596 | OSSIOfiber Compression Screw, 3.5mmSummary page 4…y Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Devices Inion FreedomScrew TM (K123672) - Primary Predicate OSSIOfiber® Compression Screw (K193660, K213596, K221193, K231272) - Additional Predicate Reference Devices OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465, K231272) OSS… | 2021 |
| * | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmSummary page 4…Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Devices Inion FreedomScrew TM (K123672) - Primary Predicate OSSIOfiber® Compression Screw (K193660, K213596, K221193, K231272) - Additional Predicate Reference Devices OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465, K231272) OSSIOfiber®… | 2022 |
| * | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable… Cleared while this submission was under review Summary page 4…21 C.F.R. § 888.3040 Product Code: HWC Predicate Devices Inion FreedomScrew TM (K123672) - Primary Predicate OSSIOfiber® Compression Screw (K193660, K213596, K221193, K231272) - Additional Predicate Reference Devices OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465, K231272) OSSIOfiber® Suture An… | 2023 |
| † | K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail… | 2021 |
| † | K213415 | OSSIOfiber Suture Anchor | 2022 |
| † | K181180 | OSSIO™ Pin Product Family | 2019 |
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 |
|---|---|---|---|
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | 2024 | 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 28 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 127 ancestors have a recall of any class.
- Of its descendants, K241277 (OSSIO, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K123672.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233198: OSSIOfiber® Threaded Trimmable Fixation Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233198
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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