510(k) · Cleared
ClearedOSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OSSIO, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Dec 1, 2023 as substantially equivalent to K181180 (OSSIO, Ltd., 2019) and 6 other predicates after a 213-day review. Its family tree reaches back 14 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 1, 2023
- Review
- 213 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K962616 (1996). 126 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 2 generations backK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- 1 generation backK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- This deviceK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK233198 OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK241277 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK254077 OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 3 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 2 generations backK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
- 1 generation backK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- This deviceK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd. · 2024 · cites it directly2descendants
- K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2024 · cites it directly1descendant
- K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −3 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| −2 | K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | 2020 | — |
| −1 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
| 0 (this device) | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®… | OSSIO, Ltd. | 2023 | — |
| +1 | K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO, Ltd. | 2024 | — |
| +1 | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | 2024 | — |
| +1 | 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 | 2 | 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 HTY? 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 HTY device
- #1 K250646 Impact PEEK Union Nail Systemscore 16.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K181180 | OSSIO™ Pin Product FamilySummary page 7…r threaded metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HTY Predicate: OSSIO® Pin Product Family (K181180) – Primary Predicate • Name of Device: OSSIOfiber® Compression Screw Common or Usual Name: Screw, Fixation, Bone C… | 2019 |
| * | K193660 | OSSIOfiber™ Compression ScrewsSummary page 7…readed metallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate: OSSIOfiber® Compression Screw (K193660, K213596, K221193) – Additional Predicate DePuy Synthes Screws (K161616) – Additional Predicat… | 2020 |
| * | K213596 | OSSIOfiber Compression Screw, 3.5mmSummary page 7…tallic bone fixation fastener Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate: OSSIOfiber® Compression Screw (K193660, K213596, K221193) – Additional Predicate DePuy Synthes Screws (K161616) – Additional Predicate • Na… | 2021 |
| * | K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmSummary page 7…Regulatory Class: Class II, 21 C.F.R. § 888.3040 Product Code: HWC Predicate: OSSIOfiber® Compression Screw (K193660, K213596, K221193) – Additional Predicate DePuy Synthes Screws (K161616) – Additional Predicate • Name of Device: OSSIOfiber® Cann… | 2022 |
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 7…Code: HWC Predicate: OSSIOfiber® Compression Screw (K193660, K213596, K221193) – Additional Predicate DePuy Synthes Screws (K161616) – Additional Predicate • Name of Device: OSSIOfiber® Cannulated Trimmable Fixation Nail, OSSIOfiber® Tri… | 2017 |
| * | K203465 | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail…Summary page 7…ixation Nail, OSSIOfiber® Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, Cannulated Design (K203465, K230750) – Additional Predicate… | 2021 |
| * | K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail Cleared while this submission was under review Summary page 7…ail, OSSIOfiber® Trimmable Fixation Nail, OSSIOfiber® Trimmable Fixation Nail, Cannulated Design (K203465, K230750) – Additional Predicate… | 2023 |
What descends from it? (3)
3 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 27 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 126 ancestors have a recall of any class.
- Of its descendants, K233198 (OSSIO, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K181180.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
OSSIOfiber® Compression Screws 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. The…
Read the full statement (188 words)
OSSIOfiber® Compression Screws 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.
The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) 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.
The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) 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/K231272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231272: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231272
Report an extraction error
Are you the manufacturer?
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