510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Modular Arthrodesis Nail

K042409510(k) TraditionalCleared Dec 2, 200490-day reviewClass II21 CFR 888.3020Recalls 2

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

Biomet, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 2, 2004 as substantially equivalent to K993603 (Howmedica Osteonics Corp., 1999) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1998. It has been recalled 2 times.

Decided
Dec 2, 2004
Review
90 days
Class
Class II
Product code
HSB
Recalls
2
Predicates
4

Its longest line of descent runs back 1 generation to K982953 (1998). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestorK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled199619982000200220042006
Other ancestors, by generation 1 generation back: 3 other ancestors K982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled0
  1. Root · 1 generation backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
  2. This deviceK042409 Modular Arthrodesis NailBiomet, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982953Titanium Intramedullary Nails-Various StylesBiomet, Inc.19984
0 (this device)K042409Modular Arthrodesis NailBiomet, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200210
FIG. 1 — Lineage of K042409, 1998–2004Source: 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
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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
*K993603Wichita Fusion Nail Fully Threaded Self-Tapping Screw
Summary page 1
…y and Accessories (21 CFR §888.3020) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Wichita s Fusion Nail - llowmedica Inc. (K993603) Titanium Intramedullary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howme…
Howmedica Osteonics Corp.1999—
*K982953Titanium Intramedullary Nails-Various Styles
Summary page 1
…bstantial Equivalence Is Claimed: Wichita s Fusion Nail - llowmedica Inc. (K993603) Titanium Intramedullary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howmedica Inc. (K020384) Orthopedic Salvage System - Biomet…
Biomet, Inc.19984
*K020384T2 Arthrodesis Nail System
Summary page 1
…il - llowmedica Inc. (K993603) Titanium Intramedullary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howmedica Inc. (K020384) Orthopedic Salvage System - Biomet Inc. (K002757) Device Description: The Modular Arthrodesis Nail is a mul…
Howmedica Osteonics Corp.20021
*K002757Oncology Salvage System
Summary page 1
…lary Nails - Biomet Inc. (K982953) T2 Arthrodesis Nail System - Howmedica Inc. (K020384) Orthopedic Salvage System - Biomet Inc. (K002757) Device Description: The Modular Arthrodesis Nail is a multi-component device designed to provide arthrodcsis fixation of the kn…
Biomet, Inc.200014

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 29, 2022Class IIZ-1036-2023Process controlProduct missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Apr 3, 2018Class IIZ-1522-2018Nonconforming Material/ComponentThere is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 3 of the 4 ancestors have a recall of any class.

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?

The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

Indications include:

1. Treatment of patients who are not candidates for total knee arthroplasty

2. Irretrievably failed total knee arthroplasty

3. Limb salvage in oncology surgery

4. Trauma

5. Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice.

These devices are intended for cemented use only.

Indications for use as stated in the FDA summary.

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in HSB

The HSB category page

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  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
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https://510kreport.com/device/K042409 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042409: Modular Arthrodesis Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042409

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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