510(k) Report

510(k) · Cleared

Recalled · 2005

Reliance PF Femoral Stems

K970200510(k) TraditionalCleared Apr 9, 199778-day reviewClass II21 CFR 888.3353Recalls 1

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 Apr 9, 1997 as substantially equivalent to K903563 (Howmedica Corp., 1991) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.

Decided
Apr 9, 1997
Review
78 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K903563 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestorsK903563 · Howmedica HNR System · Howmedica Corp. · 199119901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K903563 · Howmedica HNR System · Howmedica Corp. · 19910
  1. Root · 1 generation backK903563 Howmedica HNR SystemHowmedica Corp. · 1991
  2. This deviceK970200 Reliance PF Femoral StemsHowmedica Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903563Howmedica HNR SystemHowmedica Corp.1991—
0 (this device)K970200Reliance PF Femoral StemsHowmedica Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
FIG. 1 — Lineage of K970200, 1991–1997Source: 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
*K903563Howmedica HNR System
Summary page 1
…stem is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System. Testing h…
Howmedica Corp.1991—
*K936126Howmedics DRG Femoral Component
Summary page 1
…n intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System. Testing has demonstrated that the enduranc…
Howmedica, Inc.1994—
*K936127Howmedica Premium Femoral Component
Summary page 1
…erational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System. Testing has demonstrated that the endurance load exceeds the Semlitsch minimum…
Howmedica, Inc.19941
*—Dow Corning Wright's McCutchen Hip System
Named without a submission number
—

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
Aug 24, 2005Not classifiedZ-0108-06OtherThe 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?

  • 1 of the 3 ancestors has a recall of any class.

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 Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.

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 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/K970200 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970200: Reliance PF Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970200

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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