510(k) · Cleared
ClearedOmni Foot and Ankle 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 Aug 20, 2021 as substantially equivalent to K180808 (Extremity Medical, LLC, 2018) and 3 other predicates after a 29-day review. Its family tree reaches back 15 generations to 1996. 1 later device descends from it.
- Decided
- Aug 20, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K954385 (1996). 299 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 2 generations backK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- 1 generation backK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- This deviceK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK221362 Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 6 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 5 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 2 generations backK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- 1 generation backK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- This deviceK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −6 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −5 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −2 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| −1 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| 0 (this device) | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +1 | K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 7 | 0 |
| 1996 | 18 | 0 |
| 1997 | 9 | 0 |
| 1998 | 10 | 0 |
| 1999 | 12 | 0 |
| 2000 | 14 | 0 |
| 2001 | 22 | 0 |
| 2002 | 22 | 0 |
| 2003 | 12 | 0 |
| 2004 | 11 | 0 |
| 2005 | 20 | 0 |
| 2006 | 16 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 15 | 0 |
| 2010 | 14 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K180808 | Omni Foot Plating SystemSummary page 4…llic bone fixation fastener HRS (plate, fixation, bone) (Primary) Product Code HWC (screw, fixation, bone) Primary K180808 – Omni Foot Plating System Predicate K170780 - ARIX Foot System (2.3/2.8) Additional K163044… | 2018 |
| * | K170780 | ARIX Foot System (2.3/2.8)Summary page 4…tion, bone) (Primary) Product Code HWC (screw, fixation, bone) Primary K180808 – Omni Foot Plating System Predicate K170780 - ARIX Foot System (2.3/2.8) Additional K163044 - ORTHOLOC® 3Di Ankle Fracture Plating System Predicates… | 2017 |
| * | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating SystemSummary page 4…ixation, bone) Primary K180808 – Omni Foot Plating System Predicate K170780 - ARIX Foot System (2.3/2.8) Additional K163044 - ORTHOLOC® 3Di Ankle Fracture Plating System Predicates K181067 – AlignX Ankle Fusion System… | 2017 |
| * | K181067 | AlignX Ankle Fusion SystemSummary page 4…te K170780 - ARIX Foot System (2.3/2.8) Additional K163044 - ORTHOLOC® 3Di Ankle Fracture Plating System Predicates K181067 – AlignX Ankle Fusion System The Omni Foot and Ankle Plating System is a bone fixation system consisting of un… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221362 | Omni Foot and Ankle Plating System | 2022 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 52 of the 299 ancestors have a recall of any class.
- Of its descendants, K221362 (Exremity Medical, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 and Ankle Plating System is intended for use in internal fixation of arthrodesis, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212297: Omni Foot and Ankle 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/K212297
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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