510(k) · Cleared
ClearedFixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferguson Medical · HRS Plate, Fixation, Bone
Cleared on May 22, 1997 as substantially equivalent to K954757 (Ferguson Medical, 1996) and 2 other predicates after a 119-day review. Its family tree reaches back 2 generations to 1985. 8 later devices descend from it.
- Decided
- May 22, 1997
- Review
- 119 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K850886 (1985). 7 ancestors in all, the oldest K791619 (1979). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
- 1 generation backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
- This deviceK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
- Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK063709 TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK072175 Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK063033 Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
- K063709TS-Bone Hip ToolOrthopedic Sciences, Inc. · 2007 · 2 generations on1descendant
- K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004 · 2 generations on1descendant
- K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc. · 2007 · 3 generations on0descendants
- K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850886 | Compression Hip Screw System | Pfizer, Inc. | 1985 | 1 |
| −1 | K955306 | Omega+ Compression Screw System | Howmedica Corp. | 1996 | 1 |
| 0 (this device) | K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable… | Ferguson Medical | 1997 | — |
| +1 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +2 | K063709 | TS-Bone Hip Tool | Orthopedic Sciences, Inc. | 2007 | — |
| +2 | K040850 | Tsy Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2004 | — |
| +3 | K072175 | Titanium Hip Tool Locking Plate | Orthopedic Sciences, Inc. | 2007 | — |
| +3 | K063033 | Modification to Titanium Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K954757 | Fixano D.D.S. (Double Sliding Screw)Summary page 1…o D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures. B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Synthes Dynamic Hip Screw (DHS) (K791619), Howmedica Omega Plus Compression Hip Screw System (K955306), and others. C. Device… | 1996 |
| * | K791619 | Dynamic Hip ScrewSummary page 1…Osteosynthesis of Unstable Femoral Neck Fractures. B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Synthes Dynamic Hip Screw (DHS) (K791619), Howmedica Omega Plus Compression Hip Screw System (K955306), and others. C. Device description: The Fixano D.S.S. (Double Slid… | 1979 |
| * | K955306 | Omega+ Compression Screw SystemSummary page 1…antial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Synthes Dynamic Hip Screw (DHS) (K791619), Howmedica Omega Plus Compression Hip Screw System (K955306), and others. C. Device description: The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Nec… | 1996 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022139 | Hip Tool Implant | 2002 | 7 |
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 12 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K022139 (Orthopedic Sciences, Inc., 2002) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K954757.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
This device is indicated for use in the fixation of unstable femoral neck fractures.
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/K970258 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970258: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970258
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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