510(k) Report

510(k) · Cleared

Cleared

Meridian Titanium Femoral Stems

K972228510(k) TraditionalCleared Dec 5, 1997175-day reviewClass II21 CFR 888.3353

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

Howmedica, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Dec 5, 1997 as substantially equivalent to K940307 (Howmedica, Inc., 1995) and 2 other predicates after a 175-day review. Its family tree reaches back 1 generation to 1994. 255 later devices descend from it.

Decided
Dec 5, 1997
Review
175 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K941141 (1994). 3 ancestors in all. 255 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors2000: 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 clearedK941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 22 descendants3 generations forward: 52 descendants4 generations forward: 43 descendants5 generations forward: 41 descendants6 generations forward: 23 descendants7 generations forward: 6 descendants8 generations forward: 21 descendants9 generations forward: 20 descendants10 generations forward: 14 descendants11 generations forward: 8 descendants K941141 · Precision Ostelock SP Femoral Component · Howmedica Corp. · 19940+5+10
  1. Root · 1 generation backK941141 Precision Ostelock SP Femoral ComponentHowmedica Corp. · 1994
  2. This deviceK972228 Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  3. Descendant · cites it directly · 224 of its ownK993768 Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · Recalled
  4. Descendant · 2 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  5. Descendant · cites it directly · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  6. Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  7. Descendant · 4 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008

Showing 5 of 255 descendants. See all descendants

Descendants cleared per year

2000: 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
2000high 23 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 255 · See all
  • K993768Citation TMZF HA StemHowmedica Osteonics Corp. · 2000 · cites it directly224descendants
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 2 generations on150descendants
  • K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · cites it directly101descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
  • K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 4 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941141Precision Ostelock SP Femoral ComponentHowmedica Corp.1994—
0 (this device)K972228Meridian Titanium Femoral StemsHowmedica, Inc.1997—
+1K993768Citation TMZF HA StemHowmedica Osteonics Corp.200012
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+1K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
+3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K972228, 1994–2026Source: 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), 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (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
*K940307Howmedica Straight Stem Femoral Component
Summary page 1
…m Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® Femoral Stem (K940307), Osteolock™ CL Femoral Stem, TMZF (K944592), and Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141); and Osteonics' Arc Deposition…
Howmedica, Inc.19951
*K944592Precision Osteolock Femoral Component
Summary page 1
…nce in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® Femoral Stem (K940307), Osteolock™ CL Femoral Stem, TMZF (K944592), and Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141); and Osteonics' Arc Deposition Hip Components. Fatigue endurance testing i…
Howmedica Corp.1995—
*K941141Precision Ostelock SP Femoral Component
Summary page 1
…indications and contraindications to Howmedica's Meridian® Femoral Stem (K940307), Osteolock™ CL Femoral Stem, TMZF (K944592), and Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141); and Osteonics' Arc Deposition Hip Components. Fatigue endurance testing in accordance with ISO standards was presented. === P…
Howmedica Corp.1994—
*—Osteonics' Arc Deposition Hip Components
Named without a submission number
—

What descends from it? (255)

See all 255

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

NumberDeviceApplicantDecidedDescendants
K993768Citation TMZF HA StemHowmedica Osteonics Corp.2000224
K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.2002101
K994366TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemHowmedica Osteonics Corp.200076
K110290Exeter Hip StemHowmedica Osteonics Corp.201137
K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.200713

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K993768 (Howmedica Osteonics Corp., 2000) has gone furthest, with 224 descendants of its own.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K972228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972228: Meridian Titanium Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972228

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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