510(k) Report

510(k) · Cleared

Cleared

Foundation Porous Hip Stem

K991226510(k) TraditionalCleared Jun 1, 199950-day reviewClass II21 CFR 888.3353

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

Encore Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 1, 1999 after a 50-day review. The FDA summary names no predicate by number. 28 later devices descend from it.

Decided
Jun 1, 1999
Review
50 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2010: 1 descendant cleared2003: 1 descendant cleared2015: 2 descendants cleared2014: 4 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2022: 3 descendants cleared2017: 3 descendants cleared2025: 1 descendant cleared2026: 3 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK991226 Foundation Porous Hip StemEncore Orthopedics, Inc. · 1999
  2. Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  3. Descendant · 2 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
  4. Descendant · 2 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
  5. Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
  6. Descendant · 3 generations on · 6 of its ownK173104 Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD®…Total Joint Orthopedics, Inc. · 2017

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2003: 12010: 12012: 12014: 42015: 22016: 12017: 32018: 22019: 12021: 22022: 32023: 22024: 12025: 12026: 3
2003high 4 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 28 · See all
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
  • K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 2 generations on16descendants
  • K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 2 generations on14descendants
  • K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
  • K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc. · 2017 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991226Foundation Porous Hip StemEncore Orthopedics, Inc.1999—
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2010—
+2K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.2014—
+2K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.2014—
+3K163577Ecofit® Hip SystemImplantcast GmbH20171
+3K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low…Total Joint Orthopedics, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
201210
201440
201520
201610
201730
201820
201910
202120
202230
202320
202410
202510
202630
FIG. 1 — Lineage of K991226, 1999–2026Source: 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025
K121024Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous…Encore Medical L.P.20120
K032385Global Press-Fit StemGlobal Medical Co.20030

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, K100445 (Total Joint Orthopedics, Inc., 2010) has gone furthest, with 25 descendants of its own.

How does its category compare?

All LZO devices

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

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The indications for use of the Foundation® Porous total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is intended to be used in a cementless mode.

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K991226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991226: Foundation Porous Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991226

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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