510(k) Report

510(k) · Cleared

Cleared

Alta Fully Threaded Cross-Locking Screws

K963398510(k) TraditionalCleared Oct 10, 199642-day reviewClass II21 CFR 888.3040

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

Howmedica Corp. · HWC Screw, Fixation, Bone

Cleared on Oct 10, 1996 as substantially equivalent to K850441 (Pfizer, Inc., 1985) and 7 other predicates after a 42-day review. Its family tree reaches back 2 generations to 1982.

Decided
Oct 10, 1996
Review
42 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K813371 (1982). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor1989: 2 other ancestors1985: 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: 7 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 deviceK963398 Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp. · 1996
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)K963398Alta Fully Threaded Cross-Locking ScrewsHowmedica Corp.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198920
199210
199310
199410
199510
FIG. 1 — Lineage of K963398, 1982–1996Source: 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 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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (11)

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
*K850441Mec Intramedullary Rod
Summary page 1
…quivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K8…
Pfizer, Inc.1985—
*K922266Alta Femoral Intramedullary Rod System, Add Sizes
Summary page 1
…in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K9…
Howmedica Corp.1992—
*K926232Alta CFX Rod System
Summary page 1
…l principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and…
Howmedica Corp.1993—
*K935295Alta Femoral Intramedullary Rods/CFX Rods Modification
Summary page 1
…les, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrogr…
Howmedica Corp.1994—
*K960524Alta CFX IM Rod System
Summary page 1
…elative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femora…
Howmedica Corp.1996—
*K884500Alta Non-Reamed Tibial Rod
Summary page 1
…dica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Rec…
Howmedica Corp.1989—
*K890936Alta Hollow Tibial Rods
Summary page 1
…ta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Recon Nail.
Howmedica Corp.1989—
*K954554Alta Tibial/Humeral Rod
Summary page 1
…l Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Recon Nail.
Howmedica Corp.1995—
*—Uniflex Tibial Nail System
Named without a submission number
—
*—Retrograde Femoral Nail System
Named without a submission number
—
*—ZMS Intramedullary Recon Nail
Named without a submission number
—

Also cleared against K850441: 1 other device →

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 14 years and passes through 1 company; a new generation was cleared every 14.1 years on median.
  • None of the 9 ancestors has a recall.
  • 1 other device also cites its predicate K850441.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.

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 K850441

1 other device cites the same predicate.

  • K960524Alta CFX IM Rod SystemHowmedica 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 HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K963398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963398: Alta Fully Threaded Cross-Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963398

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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