510(k) Report

510(k) · Cleared

Cleared

Modular Acetabular Cup System

K920430510(k) TraditionalCleared Jul 21, 1992169-day reviewClass II21 CFR 888.3350

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. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jul 21, 1992 after a 169-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 121 later devices descend from it.

Decided
Jul 21, 1992
Review
169 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
0

121 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2018: 7 descendants cleared2022: 10 descendants cleared2017: 11 descendants cleared2013: 8 descendants cleared2006: 1 descendant cleared2012: 10 descendants cleared2007: 1 descendant cleared2010: 6 descendants cleared2009: 1 descendant cleared2020: 2 descendants cleared2019: 7 descendants cleared2024: 6 descendants cleared2023: 7 descendants cleared2011: 8 descendants cleared2015: 6 descendants cleared2025: 8 descendants cleared2016: 4 descendants cleared2014: 5 descendants cleared2021: 4 descendants cleared2026: 9 descendants cleared1990200020102020
  1. This deviceK920430 Modular Acetabular Cup SystemSmith & Nephew Richards, Inc. · 1992
  2. Descendant · cites it directly · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
  3. Descendant · 2 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
  5. Descendant · 2 generations on · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
  6. Descendant · 3 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 12010: 62011: 82012: 102013: 82014: 52015: 62016: 42017: 112018: 72019: 72020: 22021: 42022: 102023: 72024: 62025: 82026: 9
2006high 11 (2017) · low 0 (2008)2026

Most influential descendants

Showing 5 of 121 · See all
  • K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · cites it directly120descendants
  • K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 2 generations on91descendants
  • K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · 2 generations on46descendants
  • K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · 2 generations on35descendants
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 3 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920430Modular Acetabular Cup SystemSmith & Nephew Richards, Inc.1992—
+1K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006—
+2K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.20076
+2K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.2009—
+2K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.2010—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200910
201060
201180
2012100
201380
201450
201560
201640
2017110
201870
201970
202020
202140
2022100
202370
202460
202580
202690
FIG. 1 — Lineage of K920430, 1992–2026Source: 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006120
K182535R3 Anteverted LinersSmith & Nephew, Inc.20184
K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130

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, K061253 (Smith & Nephew, Inc., 2006) has gone furthest, with 120 descendants of its own.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

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 JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K920430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920430: Modular Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920430

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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