510(k) · Cleared
ClearedAce Cancellous Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Co. · HWC Screw, Fixation, Bone
Cleared on Aug 17, 1987 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Aug 17, 1987
- Review
- 27 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK872859 Ace Cancellous Bone ScrewAce Medical Co. · 1987
- Descendant · cites it directly · 16 of its ownK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 8 of its ownK143188 3.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK213199 Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw…Stryker GmbH · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K140891Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · cites it directly16descendants
- K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · 2 generations on8descendants
- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · 2 generations on3descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · 3 generations on3descendants
- K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872859 | Ace Cancellous Bone Screw | Ace Medical Co. | 1987 | — |
| +1 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| +2 | K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014 | 1 |
| +2 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +3 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +2 | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | Stryker GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K140891 (Biomet, Inc., 2014) has gone furthest, with 16 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/K872859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K872859: Ace Cancellous Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872859
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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