510(k) · Cleared
ClearedHowmedica and Howmedica Leibinger Bone Screw Washers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · HWC Screw, Fixation, Bone
Cleared on Apr 29, 1998 after a 90-day review. The FDA summary names its predicate without a number. 82 later devices descend from it.
- Decided
- Apr 29, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 1 citing it directly.
- This deviceK980364 Howmedica and Howmedica Leibinger Bone Screw WashersHowmedica Corp. · 1998
- Descendant · cites it directly · 81 of its ownK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- Descendant · 2 generations on · 61 of its ownK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- Descendant · 3 generations on · 58 of its ownK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- Descendant · 3 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · 3 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K062498Profyle SystemHowmedica Osteonics Corp. · 2006 · cites it directly81descendants
- K073527Variax Elbow SystemHowmedica Osteonics Corp. · 2008 · 2 generations on61descendants
- K101056Variax Elbow SystemHowmedica Osteonics Corp. · 2010 · 3 generations on58descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 3 generations on40descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980364 | Howmedica and Howmedica Leibinger Bone Screw Washers | Howmedica Corp. | 1998 | — |
| +1 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| +2 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| +3 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| +3 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| +3 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 15 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | — | Howmedica’s Large Cancellous Washer Named without a submission number | |
| * | — | Vitallium Washer Named without a submission number | |
| * | — | ICS Mini and Small Fregment Set Washer Named without a submission number | |
| * | — | Synthes® Mini Fragment Implant Set Washer Named without a submission number | |
| * | — | Schuhli Washer Named without a submission number |
What descends from it? (82)
See all 821 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062498 | Profyle System | 2006 | 81 |
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, K062498 (Howmedica Osteonics Corp., 2006) has gone furthest, with 81 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 | — |
What is it indicated for?
The washers are intended to be used to provide additional surface arez contact between the screw head and bone surface, when used in combination with bone screws for small bone reconstruction of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.
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/K980364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980364: Howmedica and Howmedica Leibinger Bone Screw Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980364
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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