510(k) · Cleared
ClearedAvanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanti Orthopaedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 23, 2022 as substantially equivalent to K161616 (Synthes USA Products, LLC, 2017) and 2 other predicates after a 57-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Nov 23, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K962616 (1996). 142 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK222967 Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti…Avanti Orthopaedics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK222967 Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti…Avanti Orthopaedics, Inc. · 2022
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 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −1 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| 0 (this device) | K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics… | Avanti Orthopaedics, Inc. | 2022 | — |
| +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 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 5…n Device Class: II Subject Device Primary Predicate Avanti Orthopaedics 2.2mm and K161616 DePuy Synthes 2.4 mm 2.7mm Cannulated Compression Cannulated Screws Primary Predicate Screws… | 2017 |
| * | K180541 | DePuy Synthes 2.0 mm Quick Insertion ScrewsSummary page 5…crews Screws Subject Device Additional Predicate(s) Avanti Orthopaedics 2.2mm and K180541 DePuy Synthes 2.0 mm 2.7mm Cannulated Compression Quick Insertion Screws Additional Predicate Screws… | 2018 |
| * | K162825 | CAPTIVATE™ Compression ScrewsSummary page 5…2.0 mm 2.7mm Cannulated Compression Quick Insertion Screws Additional Predicate Screws Avanti Orthopaedics 3.2mm and K162825 CAPTIVATE™ 4.0mm Cannulated Compression Compression Screws Screws… | 2017 |
| † | K191118 | Avanti Distal Radius and Forearm System | 2019 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 25 of the 142 ancestors have a recall of any class.
- Of its descendants, K261145 (Avanti Orthopaedics, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K161616.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixation of fractures…
Read the full statement (110 words)
The Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222967: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222967
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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