510(k) Report

510(k) · Cleared

Cleared

Porocoat Mark II Total Elbow

K872084510(k) TraditionalCleared Jun 25, 198727-day reviewClass II21 CFR 888.3150

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

Depuy, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented

Cleared on Jun 25, 1987 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 25, 1987
Review
27 days
Class
Class II
Product code
JDC
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2006: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK872084 Porocoat Mark II Total ElbowDepuy, Inc. · 1987
  2. Descendant · cites it directly · 2 of its ownK992656 Depuy Total Elbow SystemDePuy Orthopaedics, Inc. · 1999 · Recalled
  3. Descendant · cites it directly · 0 of its ownK060696 Acclaim Total Elbow SystemDePuy Orthopaedics, Inc. · 2006
  4. Descendant · 2 generations on · 0 of its ownK042664 LPS Upper ExtremityDepuy, Inc. · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K992656Depuy Total Elbow SystemDePuy Orthopaedics, Inc. · 1999 · cites it directly2descendants
  • K060696Acclaim Total Elbow SystemDePuy Orthopaedics, Inc. · 2006 · cites it directly0descendants
  • K042664LPS Upper ExtremityDepuy, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K872084Porocoat Mark II Total ElbowDepuy, Inc.1987—
+1K992656Depuy Total Elbow SystemDePuy Orthopaedics, Inc.19992
+1K060696Acclaim Total Elbow SystemDePuy Orthopaedics, Inc.2006—
+2K042664LPS Upper ExtremityDepuy, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200610
FIG. 1 — Lineage of K872084, 1987–2006Source: 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.

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  • Recall history across each candidate’s familyin 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K992656Depuy Total Elbow SystemDePuy Orthopaedics, Inc.19992
K060696Acclaim Total Elbow SystemDePuy Orthopaedics, Inc.20060

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, K992656 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All JDC devices

JDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDC

2in 2019

2009: 12013: 12015: 12016: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDC

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

Recalls per year · JDC

2in 2019

2008: 22009: 62011: 22012: 22019: 22026 (partial year): 1
2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDC

212in 2025

2007: 332008: 472009: 452010: 862011: 622012: 792013: 742014: 792015: 2392016: 1762017: 4012018: 2482019: 1902020: 1792021: 1572022: 1292023: 1892024: 1752025: 212
2007high 401 (2017) · low 33 (2007)2025

MAUDE reports naming product code JDC, 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—033
20080—247
20091—645
20100—086
20110—262
20120—279
20131—074
20140—079
20151—0239
20161—0176
20170—0401
20180—0248
20192—2190
20200—0179
20210—0157
20220—0129
20230—0189
20240—0175
20250—0212
20260—1—
Cite this page

510(k) Report. “K872084: Porocoat Mark II Total Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872084

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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