510(k) · Cleared
Recalled · Class II · 2013Asnis Iii Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HWC Screw, Fixation, Bone
Cleared on Apr 3, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 917 devices in its family, counting itself, has a Class I recall. 916 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2000
- Review
- 83 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
916 later devices descend from it, 21 citing it directly. 1 of the 917 devices in this family, counting this one, has a Class I recall.
- This deviceK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000
- Descendant · cites it directly · 836 of its ownK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- Descendant · cites it directly · 531 of its ownK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- Descendant · 3 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Showing 5 of 916 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 916 · See all- K051296Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005 · cites it directly836descendants
- K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · cites it directly531descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 2 generations on487descendants
- K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · 2 generations on245descendants
- K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on241descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000080 | Asnis Iii Cannulated Screw System | Howmedica Osteonics Corp. | 2000 | — |
| +1 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| +1 | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | 1 |
| +2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +2 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| +3 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 17 | 0 |
| 2012 | 18 | 0 |
| 2013 | 18 | 0 |
| 2014 | 33 | 0 |
| 2015 | 42 | 0 |
| 2016 | 31 | 0 |
| 2017 | 59 | 0 |
| 2018 | 36 | 0 |
| 2019 | 40 | 0 |
| 2020 | 57 | 0 |
| 2021 | 71 | 1 |
| 2022 | 80 | 0 |
| 2023 | 97 | 0 |
| 2024 | 96 | 0 |
| 2025 | 95 | 0 |
| 2026 | 99 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (916)
See all 91621 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051296 | Sijf Cannulated Screw System | 2005 | 836 |
| K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | 2006 | 531 |
| K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | 2009 | 48 |
| K060428 | CSS Cannulated Screw System | 2006 | 46 |
| K071092 | Asnis Micro Cannulated Screw | 2007 | 38 |
| K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | 2017 | 35 |
| K043410 | Epiphysis Screw | 2005 | 12 |
| K171558 | ExsoMed ITN Cannulated Screw System | 2017 | 7 |
| K160617 | Large Screws Range | 2016 | 6 |
| K172596 | Large Screws Range | 2017 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2013 | Class II | Z-2099-2013 | Process control | Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K051296 (Depuy Spine, Inc., 2005) has gone furthest, with 836 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.
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 | — |
https://510kreport.com/device/K000080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000080: Asnis Iii Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000080
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026