510(k) · Cleared
ClearedOmni Foot Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extremity Medical, LLC · HRS Plate, Fixation, Bone
Cleared on Nov 6, 2017 as substantially equivalent to K161864 (Jeil Medical Corporation, 2016) and 2 other predicates after a 102-day review. Its family tree reaches back 13 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 6, 2017
- Review
- 102 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K954385 (1996). 220 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- Descendant · cites it directly · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK221362 Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK192592 Axis Plating SystemExtremity Medical, LLC · 2019
Show all 13 generations
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 11 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 10 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 9 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 8 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 7 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 6 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 5 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 4 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · cites it directly3descendants
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · 2 generations on1descendant
- K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022 · 3 generations on0descendants
- K192592Axis Plating SystemExtremity Medical, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −12 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −11 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −10 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −9 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −8 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −7 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −6 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −5 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −4 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −3 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| 0 (this device) | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| +1 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +2 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +3 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | — |
| +2 | K192592 | Axis Plating System | Extremity Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 9 | 0 |
| 1995 | 4 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 16 | 0 |
| 2002 | 21 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K161864 | ARIX Foot SystemSummary page 4…and Name and accessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener Number Product Code HRS, HWC K161864 – Arix Foot System (Jeil Medical Corporation) Predicate K140397 – ParaLock Plating System (Paragon 28) Devices… | 2016 |
| * | K140397 | Paralock Plating System / Tuffnek ScrewSummary page 4…metallic bone fixation fastener Number Product Code HRS, HWC K161864 – Arix Foot System (Jeil Medical Corporation) Predicate K140397 – ParaLock Plating System (Paragon 28) Devices K121349 – Extremity Medical Screw and Washer System… | 2014 |
| * | K121349 | IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherSummary page 4…K161864 – Arix Foot System (Jeil Medical Corporation) Predicate K140397 – ParaLock Plating System (Paragon 28) Devices K121349 – Extremity Medical Screw and Washer System The Omni Foot Plating System is a bone fixation system consisting… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180808 | Omni Foot Plating System | 2018 | 3 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 48 of the 220 ancestors have a recall of any class.
- Of its descendants, K180808 (Extremity Medical, LLC, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K161864.
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 Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.
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/K172260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172260: Omni Foot 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/K172260
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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