510(k) Report

510(k) · Cleared

Recalled · 2005

Howmedica Straight Stem Femoral Component

K940307510(k) TraditionalCleared Jan 19, 1995360-day reviewClass II21 CFR 888.3350Recalls 1

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

Howmedica, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jan 19, 1995 after a 360-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 256 later devices descend from it. It has been recalled once.

Decided
Jan 19, 1995
Review
360 days
Class
Class II
Product code
JDI
Recalls
1
Predicates
0

256 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2000: 3 descendants cleared2007: 2 descendants cleared2002: 2 descendants cleared2011: 8 descendants cleared2021: 13 descendants cleared2020: 15 descendants cleared2012: 10 descendants cleared2009: 4 descendants cleared2017: 19 descendants cleared2014: 11 descendants cleared2013: 10 descendants cleared2015: 12 descendants cleared2016: 15 descendants cleared2018: 13 descendants cleared2006: 4 descendants cleared2005: 2 descendants cleared2001: 1 descendant cleared2025: 23 descendants cleared2003: 1 descendant cleared2010: 5 descendants cleared2019: 19 descendants cleared2026: 13 descendants cleared2023: 14 descendants cleared2024: 14 descendants cleared2022: 15 descendants cleared2008: 6 descendants cleared2004: 1 descendant cleared1995200020052010201520202025
  1. This deviceK940307 Howmedica Straight Stem Femoral ComponentHowmedica, Inc. · 1995
  2. Descendant · cites it directly · 255 of its ownK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  3. Descendant · 2 generations on · 224 of its ownK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  4. Descendant · 3 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  5. Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  6. Descendant · 4 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006

Showing 5 of 256 descendants. See all descendants

Descendants cleared per year

1997: 12000: 32001: 12002: 22003: 12004: 12005: 22006: 42007: 22008: 62009: 42010: 52011: 82012: 102013: 102014: 112015: 122016: 152017: 192018: 132019: 192020: 152021: 132022: 152023: 142024: 142025: 232026: 13
1997high 23 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 256 · See all
  • K972228Meridian Titanium Femoral StemsHowmedica, Inc. · 1997 · cites it directly255descendants
  • K993768Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · 2 generations on224descendants
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 3 generations on150descendants
  • K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 4 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940307Howmedica Straight Stem Femoral ComponentHowmedica, Inc.1995—
+1K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997—
+2K993768Citation TMZF HA StemHowmedica Osteonics Corp.200012
+3K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+2K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
+4K060437Excia Total Hip System with U-CapAesculap, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200030
200110
200220
200310
200410
200520
200640
200720
200860
200940
201050
201180
2012100
2013100
2014110
2015120
2016150
2017190
2018130
2019190
2020150
2021130
2022150
2023140
2024140
2025230
2026130
FIG. 1 — Lineage of K940307, 1995–2026Source: 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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?

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

What descends from it? (256)

See all 256

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997255

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 24, 2005Not classifiedZ-0106-06OtherThe V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972228 (Howmedica, Inc., 1997) has gone furthest, with 255 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

More from Howmedica, Inc.

36 FDA decisions under this applicant name. See the company

  • K984251Xia Spine SystemHowmedica, Inc. · 1999
  • K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
  • K984305Zeta Multizone Locking Nail SystemHowmedica, Inc. · 1999
  • K983885Burr Hole Covers, Craniomaxillofacial PlatesHowmedica, Inc. · 1999
  • K983358G/K SFN and STN Locking NailsHowmedica, Inc. · 1998

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K940307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940307: Howmedica Straight Stem Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940307

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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