510(k) Report

510(k) · Cleared

Cleared

Uni-Polar Head

K896580510(k) TraditionalCleared Feb 15, 199090-day reviewClass II21 CFR 888.3360

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

Richards Medical Co., Inc. · LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Cleared on Feb 15, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Feb 15, 1990
Review
90 days
Class
Class II
Product code
LZY
Recalls
None
Predicates
0

22 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2022: 3 descendants cleared2013: 1 descendant cleared2010: 1 descendant cleared2023: 2 descendants cleared2006: 2 descendants cleared2011: 2 descendants cleared2015: 1 descendant cleared2018: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2021: 1 descendant cleared2024: 2 descendants cleared2017: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK896580 Uni-Polar HeadRichards Medical Co., Inc. · 1990
  2. Descendant · cites it directly · 19 of its ownK061243 Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006 · Recalled
  3. Descendant · cites it directly · 18 of its ownK062408 Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006
  4. Descendant · cites it directly · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
  5. Descendant · 2 generations on · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2006: 22010: 12011: 22012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 12022: 32023: 22024: 22025: 12026: 1
2006high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 22 · See all
  • K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006 · cites it directly19descendants
  • K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006 · cites it directly18descendants
  • K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · cites it directly16descendants
  • K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · 2 generations on7descendants
  • K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896580Uni-Polar HeadRichards Medical Co., Inc.1990—
+1K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc.20061
+1K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc.2006—
+1K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.2010—
+2K113848R3 Xlpe LinersSmith & Nephew, Inc.20122
+2K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201010
201120
201210
201310
201510
201610
201710
201810
201910
202110
202230
202320
202420
202510
202610
FIG. 1 — Lineage of K896580, 1990–2026Source: 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 LZY? 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 LZY device

  1. #1 K231448 TANDEM Hip Systemscore 6.4 · 10 generations · no Class I recall
Get a 510(k) Report

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? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K061243Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc.200619
K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc.200618
K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc.201016
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151
K231448TANDEM Hip SystemSmith & Nephew, Inc.20230
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130
K111145Endo HeadMedacta International20110

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?

  • Of its descendants, K061243 (Smith & Nephew, Inc., 2006) has gone furthest, with 19 descendants of its own.

How does its category compare?

All LZY devices

LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZY

1in 2023

2011: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZY

Too few LZY 510(k)s in any year since 2007 to give a median.

Recalls per year · LZY

1in 2025

2009: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LZY

74in 2025

2007: 92008: 262009: 202010: 382011: 432012: 462013: 442014: 462015: 972016: 762017: 722018: 672019: 592020: 792021: 592022: 652023: 772024: 742025: 74
2007high 97 (2015) · low 9 (2007)2025

MAUDE reports naming product code LZY, 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
20070—09
20080—026
20090—120
20100—038
20111—043
20120—046
20130—044
20140—046
20150—097
20160—076
20170—072
20180—067
20190—059
20200—079
20210—059
20220—065
20231—077
20240—074
20250—174
20260—0—

More from Richards Medical Co., Inc.

71 FDA decisions under this applicant name. See the company

  • K896106Rogozinski Spinal System, Add'l ComponentsRichards Medical Co., Inc. · 1990
  • K900628Modular Hip SystemRichards Medical Co., Inc. · 1990
  • K895241Intramedullary Hip ScrewRichards Medical Co., Inc. · 1990
  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989
  • K896204Zirconia Ceramic Head Add'l SizesRichards Medical Co., Inc. · 1989

Recent decisions in LZY

The LZY category page

  • K231448TANDEM Hip SystemSmith & Nephew, Inc. · 20231 recall
  • K111145Endo HeadMedacta International · 2011
  • K974442Pre-Powdered Nitrile Examination GlovesP.T. Latexindo Tobaperkasa · 1998
  • K915528BHR Bipolar Femoral Head ComponentImplantology Corp. · 1993
  • K915548Ionguard Titanium Modular HeadsBiomet, Inc. · 1992

https://510kreport.com/device/K896580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896580: Uni-Polar Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896580

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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