510(k) · Cleared
ClearedAnkle Fusion Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HRS Plate, Fixation, Bone
Cleared on Nov 28, 2017 as substantially equivalent to K073375 (Newdeal Sas, 2008) and 5 other predicates after a 60-day review. Its family tree reaches back 12 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 28, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K010612 (2001). 182 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations between
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- This deviceK173121 Ankle Fusion Plating SystemIn2bones Sas · 2017
- Descendant · cites it directly · 1 of its ownK213069 CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK241387 CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA · 2024
Show all 12 generations
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 11 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 10 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 9 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 8 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 7 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 6 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 5 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 4 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- This deviceK173121 Ankle Fusion Plating SystemIn2bones Sas · 2017
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 |
|---|---|---|---|---|---|
| −12 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −11 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −10 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −9 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −8 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −7 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −6 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −5 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −2 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| 0 (this device) | K173121 | Ankle Fusion Plating System | In2bones Sas | 2017 | — |
| +1 | K213069 | CoLink NeoFuse Plating System | In2bones USA, LLC | 2021 | — |
| +1 | K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 18 | 0 |
| 2002 | 15 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K073375 | Newdeal Tibiaxys SystemSummary page 5…outpatient surgery center where sterile field may be created and maintained. Predicate Devices Primary Predicate: Tibiaxys (K073375), Newdeal, Acquired by Integra LifeSciences Additional Predicates:… | 2008 |
| * | K083032 | Peri-Loc Bone Plating and Screw SystemSummary page 5…Acquired by Integra LifeSciences Additional Predicates: Peri-Loc Ankle Fusion Plating System (K083032), Smith and Nephew Ankle Fusion Plating System (K141735), Arthrex… | 2009 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 5…Predicates: Peri-Loc Ankle Fusion Plating System (K083032), Smith and Nephew Ankle Fusion Plating System (K141735), Arthrex ExtremiLock Ankle Fusion Plating System (K133691), Osteomed… | 2014 |
| * | K133691 | Extrimilock Ankle Plating SystemSummary page 5…, Smith and Nephew Ankle Fusion Plating System (K141735), Arthrex ExtremiLock Ankle Fusion Plating System (K133691), Osteomed LCP Ankle Arthrodesis Plate (K022255), Synthes Ortholoc… | 2014 |
| * | K022255 | Modofocation to Synthes Ankle Arthrodesis PlatesSummary page 5…K141735), Arthrex ExtremiLock Ankle Fusion Plating System (K133691), Osteomed LCP Ankle Arthrodesis Plate (K022255), Synthes Ortholoc3Di Ankle Fusion Plating system (K121425), WMT… | 2002 |
| * | K121425 | Ortholoc 3DI Ankle Fusion Plating SystemSummary page 5…K133691), Osteomed LCP Ankle Arthrodesis Plate (K022255), Synthes Ortholoc3Di Ankle Fusion Plating system (K121425), WMT 2… | 2012 |
What descends from it? (2)
2 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 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 30 of the 182 ancestors have a recall of any class.
- Of its descendants, K213069 (In2bones USA, LLC, 2021) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K073375.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173121: Ankle Fusion Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173121
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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