510(k) Report

510(k) · Cleared

Cleared

Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian Fractures

K970257510(k) TraditionalCleared May 22, 1997119-day reviewClass II21 CFR 888.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ferguson Medical · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 22, 1997 as substantially equivalent to K954757 (Ferguson Medical, 1996) and 3 other predicates after a 119-day review. Its family tree reaches back 2 generations to 1982.

Decided
May 22, 1997
Review
119 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K813371 (1982). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1994: 2 other ancestors1993: 1 other ancestor1985: 1 other ancestorK813371 · Grosse and Kempf Locking Nail Sys. · Howmedica Corp. · 1982K960524 · Alta CFX IM Rod System · Howmedica Corp. · 19961980198519901995
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K960524 · Alta CFX IM Rod System · Howmedica Corp. · 1996K813371 · Grosse and Kempf Locking Nail Sys. · Howmedica Corp. · 19820
  1. Root · 2 generations backK813371 Grosse and Kempf Locking Nail Sys.Howmedica Corp. · 1982
  2. 1 generation backK960524 Alta CFX IM Rod SystemHowmedica Corp. · 1996
  3. This deviceK970257 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of…Ferguson Medical · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K813371Grosse and Kempf Locking Nail Sys.Howmedica Corp.1982—
−1K960524Alta CFX IM Rod SystemHowmedica Corp.1996—
0 (this device)K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of…Ferguson Medical1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199310
199420
199610
FIG. 1 — Lineage of K970257, 1982–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K954757Fixano D.D.S. (Double Sliding Screw)
Summary page 1
…xano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub- Trochanterian Fractures. B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Lengt…
Ferguson Medical1996—
*K960524Alta CFX IM Rod System
Summary page 1
…or Osteosynthesis of Sub- Trochanterian Fractures. B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Length (K944883), and others. C. Device descripti…
Howmedica Corp.1996—
*K932174Gamma Locking Nail-Cross Locking Screws
Summary page 1
…Fractures. B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Length (K944883), and others. C. Device description: The Fixano D.S.S. (Double Sliding S…
Howmedica Corp.1994—
*K944883Gamma Locking Nail - Long Length
Summary page 1
…ouble Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Length (K944883), and others. C. Device description: The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub~Trochanterian Fr…
Howmedica Corp.1994—

Also cleared against K954757: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K954757.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

This device is indicated for use in the fixation of sub-trochanteric fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K954757

2 other devices cite the same predicate.

  • K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck FracturesFerguson Medical · 1997
  • K970280Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam FracturesFerguson Medical · 1997

More from Ferguson Medical

57 FDA decisions under this applicant name. See the company

  • K033153Dicom TheaterFerguson Medical · 2004
  • K962615Tumorlocalizer MriFerguson Medical · 1998
  • K963794PunctureneedleFerguson Medical · 1998
  • K971813EMBLAFerguson Medical · 1998
  • K972217Orthopedic Screw SystemFerguson Medical · 1997

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K970257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970257: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian Fractures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970257

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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