510(k) · Cleared
ClearedAvanti Distal Elbow ORIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanti Orthopaedics, LLC · HRS Plate, Fixation, Bone
Cleared on May 9, 2026 as substantially equivalent to K120717 (Synthes USA, 2012) and 5 other predicates after a 32-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- May 9, 2026
- Review
- 32 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 265 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 2 generations backK160995 NEOVIEW Plating SystemIn2bones Sas · 2016 · Recalled
- 1 generation backK191118 Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. · 2019
- This deviceK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 6 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 5 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 4 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 3 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 2 generations backK160995 NEOVIEW Plating SystemIn2bones Sas · 2016 · Recalled
- 1 generation backK191118 Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. · 2019
- This deviceK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −6 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −5 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −4 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −3 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −2 | K160995 | NEOVIEW Plating System | In2bones Sas | 2016 | 4 |
| −1 | K191118 | Avanti Distal Radius and Forearm System | Avanti Orthopaedics, Inc. | 2019 | — |
| 0 (this device) | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 6 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 9 | 0 |
| 1996 | 17 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 14 | 0 |
| 2001 | 21 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 16 | 0 |
| 2006 | 12 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Summary page 5…umber and accessories. 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener. Product Code(s) HRS, HWC Primary Predicate K120717 Synthes Variable Angle LCP Elbow System Additional K240613 Medartis AG APTUS Elbow Dorsal Olecranon Plates Predicates… | 2012 |
| * | K240613 | APTUS Elbow Dorsal Olecranon PlatesSummary page 5…h or threaded metallic bone fixation fastener. Product Code(s) HRS, HWC Primary Predicate K120717 Synthes Variable Angle LCP Elbow System Additional K240613 Medartis AG APTUS Elbow Dorsal Olecranon Plates Predicates K983988 Syntec Scientific Corp. Syntec-Taichung Non-Sterile… | 2024 |
| * | K983988 | Syntec-Taichung Non-Sterile Titanium Alloy Mini-PlateSummary page 5…Primary Predicate K120717 Synthes Variable Angle LCP Elbow System Additional K240613 Medartis AG APTUS Elbow Dorsal Olecranon Plates Predicates K983988 Syntec Scientific Corp. Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate K222967… | 1999 |
| * | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Summary page 5…Olecranon Plates Predicates K983988 Syntec Scientific Corp. Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate K222967 Avanti Cannulated Compression Screw System K211592 Avanti Ulnar Shortening System K19… | 2022 |
| * | K211592 | Avanti Orthopaedics Ulnar Shortening SystemSummary page 5…yntec-Taichung Non-Sterile Titanium Alloy Mini-Plate K222967 Avanti Cannulated Compression Screw System K211592 Avanti Ulnar Shortening System K191118 Avanti Distal Radius and Forearm System Device Description The Av… | 2021 |
| * | K191118 | Avanti Distal Radius and Forearm SystemSummary page 5…oy Mini-Plate K222967 Avanti Cannulated Compression Screw System K211592 Avanti Ulnar Shortening System K191118 Avanti Distal Radius and Forearm System Device Description The Avanti Distal Elbow ORIF System is a plate and screw fixation s… | 2019 |
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 42 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 51 of the 265 ancestors have a recall of any class.
- 7 other devices also cite its predicate K120717.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Distal Elbow ORIF System is intended for fixation of fractures of the olecranon, radius, and ulna in adults. Specifically,
• Olecranon plates are indicated for fixation of fractures and osteotomies, malunions and non-unions of the olecranon and proximal ulna.
• Straight and curved forearm plates are indicated for fixation of fractures and osteotomies of the radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261145: Avanti Distal Elbow ORIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261145
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026