510(k) Report

510(k) · Cleared

Cleared

Press-Fit Porous Shell

K961526510(k) TraditionalCleared Sep 17, 1996148-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 Sep 17, 1996 after a 148-day review. The FDA summary names no predicate by number. 69 later devices descend from it.

Decided
Sep 17, 1996
Review
148 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2013: 4 descendants cleared2000: 1 descendant cleared2023: 5 descendants cleared2001: 1 descendant cleared2007: 2 descendants cleared2009: 1 descendant cleared2024: 8 descendants cleared2014: 4 descendants cleared2011: 3 descendants cleared2022: 5 descendants cleared2021: 4 descendants cleared2025: 12 descendants cleared2012: 3 descendants cleared2026: 6 descendants cleared2019: 1 descendant cleared2018: 4 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961526 Press-Fit Porous ShellEncore Orthopedics, Inc. · 1996
  2. Descendant · cites it directly · 68 of its ownK972931 Plus Epf Acetabular CupHhl Consulting · 1997
  3. Descendant · 2 generations on · 67 of its ownK994146 Epf-Plus Cementless Press-Fit Acetabular CupPlus Orthopedics · 2000
  4. Descendant · 3 generations on · 63 of its ownK011719 Plus Cancellous Bone ScrewsPlus Orthopedics · 2001
  5. Descendant · 4 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  6. Descendant · 5 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

1997: 12000: 12001: 12007: 22009: 12011: 32012: 32013: 42014: 42015: 12017: 22018: 42019: 12020: 12021: 42022: 52023: 52024: 82025: 122026: 6
1997high 12 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 69 · See all
  • K972931Plus Epf Acetabular CupHhl Consulting · 1997 · cites it directly68descendants
  • K994146Epf-Plus Cementless Press-Fit Acetabular CupPlus Orthopedics · 2000 · 2 generations on67descendants
  • K011719Plus Cancellous Bone ScrewsPlus Orthopedics · 2001 · 3 generations on63descendants
  • K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 4 generations on33descendants
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 5 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961526Press-Fit Porous ShellEncore Orthopedics, Inc.1996—
+1K972931Plus Epf Acetabular CupHhl Consulting1997—
+2K994146Epf-Plus Cementless Press-Fit Acetabular CupPlus Orthopedics2000—
+3K011719Plus Cancellous Bone ScrewsPlus Orthopedics2001—
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200110
200720
200910
201130
201230
201340
201440
201510
201720
201840
201910
202010
202140
202250
202350
202480
2025120
202660
FIG. 1 — Lineage of K961526, 1996–2026Source: 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? (69)

See all 69

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

NumberDeviceApplicantDecidedDescendants
K972931Plus Epf Acetabular CupHhl Consulting199768

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, K972931 (Hhl Consulting, 1997) has gone furthest, with 68 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 Press-fit Porous Acetabular Component 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 or femoral neck fracture, and revision arthroplasty where bone loss is minimal. 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/K961526 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961526: Press-Fit Porous Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961526

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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