510(k) Report

510(k) · Cleared

Cleared

Contemporary Acetabular Component

K982670510(k) TraditionalCleared Oct 2, 199863-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

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

Cleared on Oct 2, 1998 as substantially equivalent to K924115 (Johnson & Johnson Orthopaedics, Inc., 1992) after a 63-day review. Its family tree reaches back 1 generation to 1992. 21 later devices descend from it.

Decided
Oct 2, 1998
Review
63 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K924115 (1992). 21 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2016: 1 descendant cleared2025: 5 descendants cleared2026: 2 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2022: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants clearedK924115 · Ultima All Uhmwpe Cemented Acetabular Cups · Johnson & Johnson Orthopaedics, Inc. · 19921990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 9 descendants4 generations forward: 8 descendants K924115 · Ultima All Uhmwpe Cemented Acetabular Cups · Johnson & Johnson Orthopaedics, Inc. · 19920
  1. Root · 1 generation backK924115 Ultima All Uhmwpe Cemented Acetabular CupsJohnson & Johnson Orthopaedics, Inc. · 1992
  2. This deviceK982670 Contemporary Acetabular ComponentHowmedica Corp. · 1998
  3. Descendant · cites it directly · 20 of its ownK061654 Trident Constrained Acetabular InsertHowmedica Osteonics Corp. · 2006
  4. Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK173499 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · Recalled
  6. Descendant · 3 generations on · 7 of its ownK182468 Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  7. Descendant · 3 generations on · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006: 12016: 12018: 12019: 22020: 12021: 12022: 42023: 12024: 22025: 52026: 2
2006high 5 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 21 · See all
  • K061654Trident Constrained Acetabular InsertHowmedica Osteonics Corp. · 2006 · cites it directly20descendants
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 2018 · 3 generations on8descendants
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019 · 3 generations on7descendants
  • K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K924115Ultima All Uhmwpe Cemented Acetabular CupsJohnson & Johnson Orthopaedics, Inc.1992—
0 (this device)K982670Contemporary Acetabular ComponentHowmedica Corp.1998—
+1K061654Trident Constrained Acetabular InsertHowmedica Osteonics Corp.2006—
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161
+3K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics20182
+3K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II…Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019—
+3K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201610
201810
201920
202010
202110
202240
202310
202420
202550
202620
FIG. 1 — Lineage of K982670, 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), 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 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
Get a 510(k) Report

What was it cleared against? (2)

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 treeK951242Premise All Polyethylene Cup
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*K924115Ultima All Uhmwpe Cemented Acetabular Cups
Summary page 1
…l principles, and relative indications and contraindications to Howmedica’'s Premise All Polyethylene Cup (KS12426) and Johnson & Johnson’s Ultima™ All Polyethylene Cup (K924115). ‘ AIIIIW DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corpora…
Johnson & Johnson Orthopaedics, Inc.1992—

Also cleared against K924115: 1 other device →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K061654Trident Constrained Acetabular InsertHowmedica Osteonics Corp.200620

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?

  • Its one ancestor has no recall.
  • Of its descendants, K061654 (Howmedica Osteonics Corp., 2006) has gone furthest, with 20 descendants of its own.
  • 1 other device also cites its predicate K924115.

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—

What is it indicated for?

The Contemporary Acetabular Component is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This component is designed to be cemented into the acetabulum.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K982670: Contemporary Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982670

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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