510(k) · Cleared
ClearedAvanti Distal Radius and Forearm System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanti Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 13, 2019 as substantially equivalent to K132704 (Biomet, 2013) and 4 other predicates after a 231-day review. Its family tree reaches back 12 generations to 1984. 1 later device descends from it.
- Decided
- Dec 13, 2019
- Review
- 231 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 93 ancestors in all, the oldest K791619 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 1 generation backK160995 NEOVIEW Plating SystemIn2bones Sas · 2016 · Recalled
- This deviceK191118 Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 5 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 4 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 3 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 1 generation backK160995 NEOVIEW Plating SystemIn2bones Sas · 2016 · Recalled
- This deviceK191118 Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −5 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −4 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −3 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −2 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −1 | K160995 | NEOVIEW Plating System | In2bones Sas | 2016 | 4 |
| 0 (this device) | K191118 | Avanti Distal Radius and Forearm System | Avanti Orthopaedics, Inc. | 2019 | — |
| +1 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowSummary page 4…Single/Multiplecomponentmetallicbonefixationappliancesandaccessories Code–Classification HRS,21CFR888.3030:ClassII PrimaryPredicate K132704BiometDistalRadiusVolarRim(DVR)PlatingSystem K042355SynthesLCPWristFusionPlates… | 2013 |
| * | K042355 | Synthes (Usa) LCP Wrist Fusion PlatesSummary page 4…Code–Classification HRS,21CFR888.3030:ClassII PrimaryPredicate K132704BiometDistalRadiusVolarRim(DVR)PlatingSystem K042355SynthesLCPWristFusionPlates K951304Synthes2.7MMCannulatedScrewandThreadedWasher Addi… | 2004 |
| * | K951304 | Synthes 2.7 MM Cannulated Screw and Threaded WasherSummary page 4…redicate K132704BiometDistalRadiusVolarRim(DVR)PlatingSystem K042355SynthesLCPWristFusionPlates K951304Synthes2.7MMCannulatedScrewandThreadedWasher Additional K000684SynthesSmallFragmentDynamicCompressio… | 1995 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…K042355SynthesLCPWristFusionPlates K951304Synthes2.7MMCannulatedScrewandThreadedWasher Additional K000684SynthesSmallFragmentDynamicCompressionLocking(DCL)System Predicates K160995In2BonesSASNeoviewPlate… | 2000 |
| * | K160995 | NEOVIEW Plating SystemSummary page 4…7MMCannulatedScrewandThreadedWasher Additional K000684SynthesSmallFragmentDynamicCompressionLocking(DCL)System Predicates K160995In2BonesSASNeoviewPlate TheAvantiDistalRadiusandForearmSystem… | 2016 |
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 |
|---|---|---|---|
| K261145 | Avanti Distal Elbow ORIF System | 2026 | 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 35 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 93 ancestors have a recall of any class.
- Of its descendants, K261145 (Avanti Orthopaedics, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 system intended for fixation of fractures, osteotomies, malunions, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191118: Avanti Distal Radius and Forearm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191118
Report an extraction error
Are you the manufacturer?
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