510(k) · Cleared
ClearedAsnis® III Cannulated Screw System and 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 Jan 11, 2022 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 1 other predicate after a 104-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 11, 2022
- Review
- 104 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922322 (1992). 21 ancestors in all, the oldest K872859 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
- 4 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- 3 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
- 2 generations backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
- 1 generation backK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- This deviceK213199 Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw…Stryker GmbH · 2022
- Descendant · cites it directly · 1 of its ownK220319 Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK233912 ARIX Cannulated Screw SystemJeil Medical Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922322 | Alphatec 3.5MM Znnulated Cortical Lag Screw | Alphatec Mfg., Inc. | 1992 | — |
| −4 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| −3 | K024086 | Propeller Head Small Cannulated Screw System | Biomet Orthopedics, Inc. | 2003 | — |
| −2 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
| −1 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| 0 (this device) | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
| +1 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
| +2 | K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 5…Fax: +41 32 641 66 60 Date: September 24, 2021 Primary Predicate Device: Asnis® III Cannulated Screw System (K000080) Additional Predicate Device: Biomet Cannulated Screw System (K140891) Device Description: The Asnis®… | 2000 |
| * | K140891 | Biomet Cannulated Screw SystemSummary page 5…tember 24, 2021 Primary Predicate Device: Asnis® III Cannulated Screw System (K000080) Additional Predicate Device: Biomet Cannulated Screw System (K140891) Device Description: The Asnis® III Cannulated Screw System, previously cleared in K000080,… | 2014 |
| † | K024060 | Modification to Asnis Iii Cannulated Screw System | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | 2022 | 1 |
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 30 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K220319 (Stryker GmbH, 2022) has gone furthest, with 1 descendant of its own.
- 20 other devices also cite its predicate K000080.
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 Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
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/K213199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213199: Asnis® III Cannulated Screw System and Asnis® PRO 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/K213199
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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