510(k) Report

510(k) · Cleared

Cleared

Alta CFX Rod System

K926232510(k) TraditionalCleared Jun 17, 1993188-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 Jun 17, 1993 after a 188-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 17, 1993
Review
188 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK926232 Alta CFX Rod SystemHowmedica Corp. · 1993
  2. Descendant · cites it directly · 2 of its ownK960524 Alta CFX IM Rod SystemHowmedica Corp. · 1996
  3. Descendant · 2 generations on · 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 3 of 3 · See all
  • K960524Alta CFX IM Rod SystemHowmedica Corp. · 1996 · cites it directly2descendants
  • K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian…Ferguson Medical · 1997 · 2 generations on0descendants
  • K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926232Alta CFX Rod SystemHowmedica Corp.1993—
+1K960524Alta CFX IM Rod SystemHowmedica Corp.1996—
+2K970257Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of…Ferguson Medical1997—
+1K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
FIG. 1 — Lineage of K926232, 1993–1997Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K960524Alta CFX IM Rod SystemHowmedica Corp.19962
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?

  • Of its descendants, K960524 (Howmedica Corp., 1996) has gone furthest, with 2 descendants of its own.

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—

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

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https://510kreport.com/device/K926232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926232: Alta CFX 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/K926232

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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