510(k) Report

510(k) · Cleared

Cleared

Porocoat Porous Coating/Aml Proximally-Coated Stem

K933787510(k) TraditionalCleared Apr 13, 1994252-day reviewClass II21 CFR 888.3358

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

Depuy, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 13, 1994 after a 252-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
Apr 13, 1994
Review
252 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2015: 9 descendants cleared2008: 2 descendants cleared2010: 1 descendant cleared2024: 15 descendants cleared2014: 4 descendants cleared2019: 8 descendants cleared2011: 3 descendants cleared2026: 16 descendants cleared2012: 3 descendants cleared2018: 3 descendants cleared2020: 8 descendants cleared2021: 11 descendants cleared2013: 4 descendants cleared2017: 3 descendants cleared2023: 9 descendants cleared2025: 12 descendants cleared2022: 9 descendants cleared1990200020102020
  1. This deviceK933787 Porocoat Porous Coating/Aml Proximally-Coated StemDepuy, Inc. · 1994
  2. Descendant · cites it directly · 120 of its ownK062654 Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006
  3. Descendant · 2 generations on · 72 of its ownK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
  4. Descendant · 3 generations on · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
  5. Descendant · 4 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  6. Descendant · 2 generations on · 45 of its ownK101499 Journey CR Knee SystemSmith & Nephew, Inc. · 2010

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22010: 12011: 32012: 32013: 42014: 42015: 92017: 32018: 32019: 82020: 82021: 112022: 92023: 92024: 152025: 122026: 16
2006high 16 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 121 · See all
  • K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006 · cites it directly120descendants
  • K073602Modification to: Apex Knee SystemOmnlife Science · 2008 · 2 generations on72descendants
  • K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · 3 generations on61descendants
  • K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 4 generations on60descendants
  • K101499Journey CR Knee SystemSmith & Nephew, Inc. · 2010 · 2 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933787Porocoat Porous Coating/Aml Proximally-Coated StemDepuy, Inc.1994—
+1K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006—
+2K073602Modification to: Apex Knee SystemOmnlife Science2008—
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.2008—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp2013—
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
201010
201130
201230
201340
201440
201590
201730
201830
201980
202080
2021110
202290
202390
2024150
2025120
2026160
FIG. 1 — Lineage of K933787, 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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?

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

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006120

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, K062654 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 120 descendants of its own.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

  • P830055/S379ATTUNE Revision Knee SystemDepuy, Inc. · 2026
  • P830055/S377ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System…Depuy, Inc. · 2026
  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

Recent decisions in LPH

The LPH category page

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  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K933787 · printed Nov 4, 2026

Cite this page

510(k) Report. “K933787: Porocoat Porous Coating/Aml Proximally-Coated Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933787

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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