510(k) Report

510(k) · Cleared

Cleared

Foundation Porous Coated Hemispherical Shell

K974093510(k) TraditionalCleared Jan 28, 199890-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

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

Cleared on Jan 28, 1998 after a 90-day review. The FDA summary names no predicate by number. 145 later devices descend from it.

Decided
Jan 28, 1998
Review
90 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

145 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2020: 11 descendants cleared2008: 1 descendant cleared2014: 13 descendants cleared2007: 1 descendant cleared2013: 2 descendants cleared2019: 10 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2015: 5 descendants cleared2025: 14 descendants cleared2016: 6 descendants cleared2018: 7 descendants cleared2021: 12 descendants cleared2017: 9 descendants cleared2022: 13 descendants cleared2024: 10 descendants cleared2023: 12 descendants cleared2026: 15 descendants cleared1995200020052010201520202025
  1. This deviceK974093 Foundation Porous Coated Hemispherical ShellEncore Orthopedics, Inc. · 1998
  2. Descendant · cites it directly · 103 of its ownK072888 Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked…Encore Medical L.P. · 2008
  3. Descendant · 2 generations on · 74 of its ownK112069 RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · Recalled
  4. Descendant · cites it directly · 61 of its ownK072154 Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P. · 2007 · Recalled
  5. Descendant · 3 generations on · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
  6. Descendant · 2 generations on · 38 of its ownK130365 X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013

Showing 5 of 145 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 12011: 12012: 22013: 22014: 132015: 52016: 62017: 92018: 72019: 102020: 112021: 122022: 132023: 122024: 102025: 142026: 15
2007high 15 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 145 · See all
  • K072888Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and…Encore Medical L.P. · 2008 · cites it directly103descendants
  • K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · 2 generations on74descendants
  • K072154Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P. · 2007 · cites it directly61descendants
  • K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · 3 generations on55descendants
  • K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P. · 2013 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974093Foundation Porous Coated Hemispherical ShellEncore Orthopedics, Inc.1998—
+1K072888Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked…Encore Medical L.P.2008—
+2K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.20111
+1K072154Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P.20071
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.2014—
+2K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201010
201110
201220
201320
2014130
201550
201660
201790
201870
2019100
2020110
2021120
2022130
2023120
2024100
2025140
2026150
FIG. 1 — Lineage of K974093, 1998–2026Source: 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 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 24.2 · 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?

The FDA summary names no predicate by number.

What descends from it? (145)

See all 145

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

NumberDeviceApplicantDecidedDescendants
K072888Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and…Encore Medical L.P.2008103
K072154Foundation (FMP) Porous Coated Spiked Acetabular SystemEncore Medical L.P.200761
K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213
K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212
K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144
K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141
K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200

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, K072888 (Encore Medical L.P., 2008) has gone furthest, with 103 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—

What is it indicated for?

The Foundation® Porous Coated Hemispherical Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture, and revision arthroplasty where bone loss is minimal. This system includes a metal-backed shell and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

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

More from Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • 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/K974093 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974093: Foundation Porous Coated Hemispherical Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974093

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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