510(k) Report

510(k) · Cleared

Cleared

Zirconia Ceramic Femoral Head

K935921510(k) TraditionalCleared Nov 28, 1994376-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

Smith & Nephew Richards, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Nov 28, 1994 as substantially equivalent to K854791 (Richards Medical Co., Inc., 1986) and 11 other predicates after a 376-day review. Its family tree reaches back 1 generation to 1983. 11 later devices descend from it.

Decided
Nov 28, 1994
Review
376 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
12

Its longest line of descent runs back 1 generation to K823727 (1983). 12 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1987: 2 other ancestors1986: 3 other ancestors1983: 1 other ancestor1997: 1 descendant cleared1999: 1 descendant cleared2013: 1 descendant cleared2004: 1 descendant cleared2001: 1 descendant cleared2017: 1 descendant cleared2010: 1 descendant cleared2005: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK823727 · Spectron Primary Stem Femoral Prosthes · Richard'S Medical Equip., Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K823727 · Spectron Primary Stem Femoral Prosthes · Richard'S Medical Equip., Inc. · 19830+5
  1. Root · 1 generation backK823727 Spectron Primary Stem Femoral ProsthesRichard'S Medical Equip., Inc. · 1983
  2. This deviceK935921 Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc. · 1994
  3. Descendant · cites it directly · 10 of its ownK965002 Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and…Encore Orthopedics, Inc. · 1997
  4. Descendant · 2 generations on · 9 of its ownK990261 Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999
  5. Descendant · 3 generations on · 7 of its ownK012918 Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001
  6. Descendant · 4 generations on · 4 of its ownK101451 Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010
  7. Descendant · 5 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12001: 12004: 12005: 12010: 12013: 12017: 12021: 12024: 12026: 1
1997high 1 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 11 · See all
  • K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Encore Orthopedics, Inc. · 1997 · cites it directly10descendants
  • K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics · 1999 · 2 generations on9descendants
  • K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC · 2001 · 3 generations on7descendants
  • K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc. · 2010 · 4 generations on4descendants
  • K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K823727Spectron Primary Stem Femoral ProsthesRichard'S Medical Equip., Inc.1983—
0 (this device)K935921Zirconia Ceramic Femoral HeadSmith & Nephew Richards, Inc.1994—
+1K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous…Encore Orthopedics, Inc.1997—
+2K990261Plus Ceramic Head Prostheses (Alumina and Zirkonia)Plus Orthopedics1999—
+3K012918Apex Modular Alumina Femoral HeadApex Surgical, LLC2001—
+4K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.2010—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…Corin, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198630
198720
198810
199010
199110
199320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200110
200410
200510
201010
201310
201710
202110
202410
202610
FIG. 1 — Lineage of K935921, 1983–2026Source: 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
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What was it cleared against? (12)

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
*K854791Bio-Fit Hip System
Summary page 2
…smetic Act (Act). This decision is based upon the use of the AstroMet AmZirOox balls with the stems listed below: Stem 510(k) # Stem Material Material Standard Bio-Fit K854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117…
Richards Medical Co., Inc.1986—
*K860635Opti-Fix Total Hip System
Summary page 2
…based upon the use of the AstroMet AmZirOox balls with the stems listed below: Stem 510(k) # Stem Material Material Standard Bio-Fit K854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K…
Richards Medical Co., Inc.1986—
*K921400Hip Joint Prothesis
Summary page 2
…3727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (ISO 5832/I1I) Systen K921400 Modular Hip K912…
Smith & Nephew Richards, Inc.1993—
*K823727Spectron Primary Stem Femoral Prosthes
Summary page 2
…the stems listed below: Stem 510(k) # Stem Material Material Standard Bio-Fit K854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, T…
Richard'S Medical Equip., Inc.1983—
*K823722Spectron Long, Straight Femoral Prosthes
Summary page 2
…m 510(k) # Stem Material Material Standard Bio-Fit K854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Ha…
Richard'S Medical Equip., Inc.1983—
*K881117Resubmitting of HJD Total Hip System
Summary page 2
…tem Material Material Standard Bio-Fit K854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K9214…
Richards Medical Co., Inc.1988—
*K873797TI-Fit Total Hip System
Summary page 2
…854791 CoCr (ASTM F 75) Opti-Fix K860635, Ti-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO…
Richards Medical Co., Inc.1987—
*K870128Hartford Total Hip System (Tri-Wedge)
Summary page 2
…-6A1-4V (ISO 5832/III) R921400 . Spectron K823727, CoCr (ASTM F 799) R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (I…
Richards Medical Co., Inc.1987—
*K862225International Total Hip System
Summary page 2
…R823722 HJD K881117 Ti-6A1-4V (IS0 5932/I1I) Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (ISO 5832/I1I) Systen K921400 Modular Hip K912593 CoCr (ASTM F 75) S…
Richards Medical Co., Inc.1986—
*K900628Modular Hip System
Summary page 2
…Ti-Fit K873797 Ti~6A1-4V (ISO 5832/I11I) Tri-Wedge K870128, Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (ISO 5832/I1I) Systen K921400 Modular Hip K912593 CoCr (ASTM F 75) System RMHS Monolithic K923275 Ti-6A1-4V (ISO 5…
Richards Medical Co., Inc.1990—
*K912593Modular Hip System
Summary page 2
…Ti-6A1-4V (ISO 5832/III) (Hartford) K921400 International K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (ISO 5832/I1I) Systen K921400 Modular Hip K912593 CoCr (ASTM F 75) System RMHS Monolithic K923275 Ti-6A1-4V (ISO 5832/I1I) You may, therefore, market the device, subject to the…
Smith & Nephew Richards, Inc.1991—
*K923275RMHS Monolithic Femoral Component
Summary page 2
…rnational K862225 Ti-6A1-4V (ISO 5832/I1T1) Modular Hip K900628, Ti-6A1-4V (ISO 5832/I1I) Systen K921400 Modular Hip K912593 CoCr (ASTM F 75) System RMHS Monolithic K923275 Ti-6A1-4V (ISO 5832/I1I) You may, therefore, market the device, subject to the general controls provisions of the Act and the fo…
Smith & Nephew Richards, Inc.1993—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K965002Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the…Encore Orthopedics, Inc.199710

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?

  • None of the 12 ancestors has a recall.
  • Of its descendants, K965002 (Encore Orthopedics, Inc., 1997) has gone furthest, with 10 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—

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

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/K935921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935921: Zirconia Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935921

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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