510(k) · Cleared
ClearedIntraosseous Fusion Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxano Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Sep 29, 2023 as substantially equivalent to K191995 (Subchondral Solutions, Inc., 2020) and 1 other predicate after a 115-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Sep 29, 2023
- Review
- 115 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962616 (1996). 212 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 2 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 1 generation backK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- This deviceK231649 Intraosseous Fusion Device SystemAuxano Medical, LLC · 2023
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 3 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 2 generations backK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- 1 generation backK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- This deviceK231649 Intraosseous Fusion Device SystemAuxano Medical, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −3 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −2 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| −1 | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | 1 |
| 0 (this device) | K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 18 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 17 | 0 |
| 2006 | 14 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2017 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K191995 | S4 Screw SystemSummary page 4…mber: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC PREDICATE INFORMATION Predicate Device: K191995 (S4 Screw System; Subchondral Solutions, Inc.) Additional Predicate Device: K163489 (OrthoSolutions ‘System26’ Bone Screws; Ortho… | 2020 |
| * | K163489 | OrthoSolutions 'System26' Bone ScrewsSummary page 4…tener Regulatory Class: II Product Code: HWC PREDICATE INFORMATION Predicate Device: K191995 (S4 Screw System; Subchondral Solutions, Inc.) Additional Predicate Device: K163489 (OrthoSolutions ‘System26’ Bone Screws; Ortho Solutions UK Limited) INDICATIONS FOR USE: The Intraosseous Fusion Device System i… | 2017 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 36 of the 212 ancestors have a recall of any class.
- 1 other device also cites its predicate K191995.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including: Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and…
Read the full statement (122 words)
The Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and
arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including:
Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans,
Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal
osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of
metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures,
Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures
of the fibula, malleolus, and calcaneus.
The Intraosseous Fusion Device System is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231649: Intraosseous Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231649
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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