510(k) Report

510(k) · Cleared

Cleared

Alta CFX IM Rod System

K960524510(k) TraditionalCleared Mar 22, 199646-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

Howmedica Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 22, 1996 as substantially equivalent to K926232 (Howmedica Corp., 1993) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.

Decided
Mar 22, 1996
Review
46 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K813371 (1982). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1985: 1 other ancestor1997: 1 descendant cleared1996: 1 descendant clearedK813371 · Grosse and Kempf Locking Nail Sys. · Howmedica Corp. · 198219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K813371 · Grosse and Kempf Locking Nail Sys. · Howmedica Corp. · 19820
  1. Root · 1 generation backK813371 Grosse and Kempf Locking Nail Sys.Howmedica Corp. · 1982
  2. This deviceK960524 Alta CFX IM Rod SystemHowmedica Corp. · 1996
  3. Descendant · cites it directly · 0 of its ownK970257 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of…Ferguson Medical · 1997
  4. Descendant · cites it directly · 0 of its ownK963398 Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp. · 1996

Most influential descendants

Showing 2 of 2 · See all
  • K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…Ferguson Medical · 1997 · cites it directly0descendants
  • K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K813371Grosse and Kempf Locking Nail Sys.Howmedica Corp.1982—
0 (this device)K960524Alta CFX IM Rod SystemHowmedica Corp.1996—
+1K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of…Ferguson Medical1997—
+1K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K960524, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K926232Alta CFX Rod System
Summary page 1
…ed use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® CFx IM Rod System and Alta® Femoral IM Rod System (K926232 & K850441), Howmedica's Grosse & Kempf Locking Nail (K813371A), Ace Medical's AIM Femoral System, and Zimmer's ZMS Recon Nail Sys…
Howmedica Corp.1993—
*K850441Mec Intramedullary Rod
Summary page 1
…terials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® CFx IM Rod System and Alta® Femoral IM Rod System (K926232 & K850441), Howmedica's Grosse & Kempf Locking Nail (K813371A), Ace Medical's AIM Femoral System, and Zimmer's ZMS Recon Nail System.
Pfizer, Inc.1985—
*K813371Grosse and Kempf Locking Nail Sys.
Summary page 1
…ve indications and contraindications to Howmedica's Alta® CFx IM Rod System and Alta® Femoral IM Rod System (K926232 & K850441), Howmedica's Grosse & Kempf Locking Nail (K813371A), Ace Medical's AIM Femoral System, and Zimmer's ZMS Recon Nail System.
Howmedica Corp.1982—
*—AIM Femoral System
Named without a submission number
—
*—ZMS Recon Nail System
Named without a submission number
—

Also cleared against K926232: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…Ferguson Medical19970
K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp.19960

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K970257 (Ferguson Medical, 1997) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K926232.

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?

These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

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 K926232

1 other device cites the same predicate.

  • K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp. · 1996

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K960524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960524: Alta CFX IM Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960524

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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