510(k) · Cleared
Recalled · Class II · 20126.5 MM Cancellous Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 17, 1994 after a 318-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 17, 1994
- Review
- 318 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK931665 6.5 MM Cancellous Bone ScrewEncore Orthopedics, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK190057 DJO Acetabular SystemEncore Medical L.P. · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK160895 Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK251833 EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
- Descendant · 2 generations on · 0 of its ownK242045 Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243444 Bioceram Azul® HeadKyocera Corporation · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190057DJO Acetabular SystemEncore Medical L.P. · 2019 · cites it directly2descendants
- K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016 · cites it directly2descendants
- K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025 · 2 generations on0descendants
- K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025 · 2 generations on0descendants
- K243444Bioceram Azul® HeadKyocera Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931665 | 6.5 MM Cancellous Bone Screw | Encore Orthopedics, Inc. | 1994 | — |
| +1 | K190057 | DJO Acetabular System | Encore Medical L.P. | 2019 | 5 |
| +1 | K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | Kyocera Medical Corporation | 2016 | — |
| +2 | K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025 | — |
| +2 | K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +2 | K243444 | Bioceram Azul® Head | Kyocera Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2012 | Class II | Z-0139-2013 | Labeling mix-ups | A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25… |
| Jul 16, 2012 | Class II | Z-2146-2012 | Packaging | One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190057 (Encore Medical L.P., 2019) has gone furthest, with 2 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/K931665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K931665: 6.5 MM 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/K931665
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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