510(k) Report

510(k) · Cleared

Cleared

Partnership Revision Femoral Stems

K972893510(k) TraditionalCleared Nov 3, 199790-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 Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 3, 1997 as substantially equivalent to K944592 (Howmedica Corp., 1995) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1994. 153 later devices descend from it.

Decided
Nov 3, 1997
Review
90 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K921308 (1994). 4 ancestors in all. 153 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1994: 1 other ancestor2002: 2 descendants cleared2000: 1 descendant cleared1998: 3 descendants cleared2001: 1 descendant cleared2021: 9 descendants cleared2020: 10 descendants cleared2012: 6 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2008: 1 descendant cleared2016: 11 descendants cleared2015: 8 descendants cleared2004: 1 descendant cleared2006: 1 descendant cleared2025: 14 descendants cleared2003: 1 descendant cleared2010: 2 descendants cleared2013: 5 descendants cleared2017: 13 descendants cleared2018: 6 descendants cleared2019: 14 descendants cleared2014: 4 descendants cleared2022: 11 descendants cleared2007: 1 descendant cleared2023: 7 descendants cleared2024: 9 descendants cleared2026: 9 descendants clearedK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 25 descendants4 generations forward: 34 descendants5 generations forward: 37 descendants6 generations forward: 15 descendants7 generations forward: 3 descendants8 generations forward: 8 descendants9 generations forward: 11 descendants10 generations forward: 8 descendants K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled0+5+10
  1. Root · 1 generation backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. This deviceK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. Descendant · cites it directly · 102 of its ownK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. Descendant · cites it directly · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. Descendant · cites it directly · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
  6. Descendant · 2 generations on · 68 of its ownK013676 Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · Recalled
  7. Descendant · 3 generations on · 61 of its ownK081171 Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

1998: 32000: 12001: 12002: 22003: 12004: 12006: 12007: 12008: 12009: 12010: 22011: 22012: 62013: 52014: 42015: 82016: 112017: 132018: 62019: 142020: 102021: 92022: 112023: 72024: 92025: 142026: 9
1998high 14 (2019) · low 0 (1999)2026

Most influential descendants

Showing 5 of 153 · See all
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 1998 · cites it directly102descendants
  • K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · cites it directly101descendants
  • K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · cites it directly69descendants
  • K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp. · 2001 · 2 generations on68descendants
  • K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp. · 2008 · 3 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
0 (this device)K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
+1K983404Type 3 Femoral ComponentsHowmedica Corp.19981
+1K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
+1K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.2000—
+2K013676Trident Hemispherical Acetabular ShellsHowmedica Osteonics Corp.20018
+3K081171Tritanium Acetabular Shell SystemHowmedica Osteonics Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199830
200010
200110
200220
200310
200410
200610
200710
200810
200910
201020
201120
201260
201350
201440
201580
2016110
2017130
201860
2019140
2020100
202190
2022110
202370
202490
2025140
202690
FIG. 1 — Lineage of K972893, 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK940307FDA’s K940307 is Howmedica Straight Stem Femoral Component
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
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 (K340307), Osteolock™ CL Femoral Stem, TMZF (K944592), Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141), Osteonics' Restoration Monolithic 1l Slotted Hip Stems (K951671), and Zimmer's…
Howmedica Corp.1995—
*K941141Precision Ostelock SP Femoral Component
Summary page 1
…ive indications and contraindications to Howmedica's Meridian® Femoral Stem (K340307), Osteolock™ CL Femoral Stem, TMZF (K944592), Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141), Osteonics' Restoration Monolithic 1l Slotted Hip Stems (K951671), and Zimmer's Multilock Hip Prosthesis (K921308). Testing has…
Howmedica Corp.1994—
*K951671Osteonics Restoration Monolithic II Slotted Hip Stem Series
Summary page 1
…oral Stem (K340307), Osteolock™ CL Femoral Stem, TMZF (K944592), Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141), Osteonics' Restoration Monolithic 1l Slotted Hip Stems (K951671), and Zimmer's Multilock Hip Prosthesis (K921308). Testing has demonstrated that the fatigue load carrying capacity of the Partn…
Osteonics Corp.19951
*K921308HG Multilock Hip Prosthesis W/ TI-Nidium
Summary page 1
…TMZF (K944592), Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141), Osteonics' Restoration Monolithic 1l Slotted Hip Stems (K951671), and Zimmer's Multilock Hip Prosthesis (K921308). Testing has demonstrated that the fatigue load carrying capacity of the Partnership Revision Femoral stems exceeds the minimum…
Zimmer, Inc.19941

Also cleared against K944592: 3 other devices →

What descends from it? (153)

See all 153

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

NumberDeviceApplicantDecidedDescendants
K983404Type 3 Femoral ComponentsHowmedica Corp.1998102
K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.2002101
K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069
K980813Reliance Long Stem Femoral ComponentsHowmedica, Inc.19980
K980239Partnership Calcar Femoral ComponentsHowmedica, Inc.19980

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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K983404 (Howmedica Corp., 1998) has gone furthest, with 102 descendants of its own.
  • 3 other devices also cite its predicate K944592.

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 Partnership Revision Femoral Stems 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 and 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.

Also cleared against K944592

3 other devices cite the same predicate.

  • K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998
  • K972228Meridian Titanium Femoral StemsHowmedica, Inc. · 1997
  • K971854Osteolock Acetabular Shell SystemHowmedica Corp. · 1997

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 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/K972893 · printed Nov 3, 2026

Cite this page

510(k) Report. “K972893: Partnership Revision Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K972893

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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