510(k) · Cleared
ClearedFixano D.D.S. (Double Sliding Screw)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferguson Medical · HWC Screw, Fixation, Bone
Cleared on Jan 25, 1996 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jan 25, 1996
- Review
- 101 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK954757 Fixano D.D.S. (Double Sliding Screw)Ferguson Medical · 1996
- Descendant · cites it directly · 8 of its ownK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
- Descendant · 2 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical · 1997 · cites it directly8descendants
- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 2 generations on7descendants
- K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 3 generations on1descendant
- K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 3 generations on1descendant
- K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954757 | Fixano D.D.S. (Double Sliding Screw) | Ferguson Medical | 1996 | — |
| +1 | K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable… | Ferguson Medical | 1997 | — |
| +2 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +3 | K063709 | TS-Bone Hip Tool | Orthopedic Sciences, Inc. | 2007 | — |
| +3 | K040850 | Tsy Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2004 | — |
| +4 | K072175 | Titanium Hip Tool Locking Plate | Orthopedic Sciences, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck… | 1997 | 8 |
| K970257 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian… | 1997 | 0 |
| K970280 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam… | 1997 | 0 |
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, K970258 (Ferguson Medical, 1997) has gone furthest, with 8 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/K954757 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954757: Fixano D.D.S. (Double Sliding Screw).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954757
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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