510(k) · Cleared
ClearedAsnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HWC Screw, Fixation, Bone
Cleared on Jun 10, 2022 as substantially equivalent to K213199 (Stryker GmbH, 2022) and 1 other predicate after a 127-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Jun 10, 2022
- Review
- 127 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962616 (1996). 126 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 1 generation backK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- This deviceK220319 Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022
- Descendant · cites it directly · 0 of its ownK233912 ARIX Cannulated Screw SystemJeil Medical Corporation · 2024
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 3 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 2 generations backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- 1 generation backK192745 DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- This deviceK220319 Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K233912ARIX Cannulated Screw SystemJeil Medical Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −2 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| −1 | K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019 | — |
| 0 (this device) | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
| +1 | K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 11 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemSummary page 5…June 02, 2022 Primary Predicate Device: Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199) Additional Predicate Device DePuy Synthes Trauma Screws (K192745) Device Description: The Asnis® I… | 2022 |
| * | K192745 | DePuy Synthes Trauma ScrewsSummary page 5…d Screw System and Asnis® PRO Cannulated Screw System (K213199) Additional Predicate Device DePuy Synthes Trauma Screws (K192745) Device Description: The Asnis® III Cannulated Screw System, previously cleared in K213199,… | 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 |
|---|---|---|---|
| K233912 | ARIX Cannulated Screw System | 2024 | 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 8 companies; a new generation was cleared every 1.8 years on median.
- 25 of the 126 ancestors have a recall of any class.
- Of its descendants, K233912 (Jeil Medical Corporation, 2024) has gone furthest, with 0 descendants of its own.
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 Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot. The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for: fracture fixation, fusions, osteotomies, nonunions, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot sacroiliac joint fusion for conditions…
Read the full statement (120 words)
The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.
The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:
fracture fixation, fusions, osteotomies, nonunions, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
sacroiliac joint fusion for conditions including sacroiliac joint disruptions
The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:
fracture fixation, fusions, osteotomies, nonunions, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
sacroiliac joint fusion for conditions including sacroiliac joint disruptions
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/K220319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220319: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220319
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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