510(k) Report

510(k) · Cleared

Cleared

Exeter All Plastic Acetabular Component

K936132510(k) TraditionalCleared Jun 14, 1994173-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, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jun 14, 1994 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
Jun 14, 1994
Review
173 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2015: 2 descendants cleared2025: 1 descendant cleared2014: 2 descendants cleared2016: 2 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK936132 Exeter All Plastic Acetabular ComponentHowmedica, Inc. · 1994
  2. Descendant · cites it directly · 16 of its ownK972792 Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997
  3. Descendant · 2 generations on · 15 of its ownK992153 PE-Plus Acetabular CupPlus Orthopedics · 1999
  4. Descendant · 3 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
  5. Descendant · 4 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
  6. Descendant · 4 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12012: 12013: 12014: 22015: 22016: 22017: 12019: 12021: 12023: 12024: 12025: 12026: 1
1997high 2 (2014) · low 0 (1998)2026

Most influential descendants

Showing 5 of 17 · See all
  • K972792Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997 · cites it directly16descendants
  • K992153PE-Plus Acetabular CupPlus Orthopedics · 1999 · 2 generations on15descendants
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 3 generations on13descendants
  • K141327Minima S SystemLima Corporate S.P.A. · 2014 · 4 generations on5descendants
  • K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K936132Exeter All Plastic Acetabular ComponentHowmedica, Inc.1994—
+1K972792Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp.1997—
+2K992153PE-Plus Acetabular CupPlus Orthopedics1999—
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A.2012—
+4K141327Minima S SystemLima Corporate S.P.A.2014—
+4K152903REVIVAL (TM) Modular Revision Hip StemCorin USA2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
201210
201310
201420
201520
201620
201710
201910
202110
202310
202410
202510
202610
FIG. 1 — Lineage of K936132, 1994–2026Source: 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? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K972792Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp.199716

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, K972792 (Howmedica Corp., 1997) has gone furthest, with 16 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—
Cite this page

510(k) Report. “K936132: Exeter All Plastic 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/K936132

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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