510(k) · Cleared
ClearedOSSIOfiber® Threaded Trimmable Fixation Nail
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 May 1, 2026 as substantially equivalent to K241277 (OSSIO, Ltd., 2024) and 1 other predicate after a 134-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- May 1, 2026
- Review
- 134 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K962616 (1996). 129 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- 2 generations backK233198 OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024
- 1 generation backK241277 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2024
- This deviceK254077 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 15 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 14 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 11 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 10 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 9 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 8 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 7 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 6 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 5 generations backK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- 4 generations backK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- 3 generations backK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- 2 generations backK233198 OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024
- 1 generation backK241277 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2024
- This deviceK254077 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −16 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −15 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −14 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −11 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −10 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −9 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −8 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −7 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −6 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| −5 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| −4 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
| −3 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®… | OSSIO, Ltd. | 2023 | — |
| −2 | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO, Ltd. | 2024 | — |
| −1 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2024 | — |
| 0 (this device) | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K241277 | OSSIOfiber® Threaded Trimmable Fixation NailSummary page 5…readed metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Device OSSIOfiber® Threaded Trimmable Fixation Nail (K241277) - Primary Predicate OSSIOfiber® Compression Screw (K231272)- Additional Predicate Purpose of the Submission This traditional 51… | 2024 |
| * | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…Summary page 5…ss II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate Device OSSIOfiber® Threaded Trimmable Fixation Nail (K241277) - Primary Predicate OSSIOfiber® Compression Screw (K231272)- Additional Predicate Purpose of the Submission This traditional 510(k) premarket notification is submitted to obtain clearance… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 129 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254077: OSSIOfiber® Threaded Trimmable Fixation Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254077
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026