510(k) Report

510(k) · Cleared

Cleared

Lineage a-Class Poly Liner

K052026510(k) TraditionalCleared Dec 5, 2005131-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

Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Dec 5, 2005 after a 131-day review. The FDA summary names its predicate without a number. 125 later devices descend from it.

Decided
Dec 5, 2005
Review
131 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

125 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2011: 5 descendants cleared2024: 11 descendants cleared2006: 1 descendant cleared2014: 7 descendants cleared2017: 8 descendants cleared2015: 6 descendants cleared2018: 7 descendants cleared2016: 6 descendants cleared2008: 2 descendants cleared2010: 7 descendants cleared2012: 7 descendants cleared2022: 12 descendants cleared2021: 8 descendants cleared2019: 6 descendants cleared2025: 12 descendants cleared2009: 1 descendant cleared2013: 3 descendants cleared2023: 7 descendants cleared2026: 9 descendants cleared20052010201520202025
  1. This deviceK052026 Lineage a-Class Poly LinerWrightmedicaltechnologyinc · 2005
  2. Descendant · cites it directly · 106 of its ownK062148 Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006
  3. Descendant · 2 generations on · 62 of its ownK073150 Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008
  4. Descendant · 3 generations on · 34 of its ownK100555 Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · Recalled
  5. Descendant · 3 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  6. Descendant · 3 generations on · 24 of its ownK101575 Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models…Omnlife Science · 2010

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22009: 12010: 72011: 52012: 72013: 32014: 72015: 62016: 62017: 82018: 72019: 62021: 82022: 122023: 72024: 112025: 122026: 9
2006high 12 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 125 · See all
  • K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006 · cites it directly106descendants
  • K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc. · 2008 · 2 generations on62descendants
  • K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc. · 2010 · 3 generations on34descendants
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 3 generations on25descendants
  • K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science · 2010 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052026Lineage a-Class Poly LinerWrightmedicaltechnologyinc2005—
+1K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006—
+2K073150Apex-LNK Poly Acetabular Cup LinersOmni Life Science, Inc.2008—
+3K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.20101
+3K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2010—
+3K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
200910
201070
201150
201270
201330
201470
201560
201660
201780
201870
201960
202180
2022120
202370
2024110
2025120
202690
FIG. 1 — Lineage of K052026, 2005–2026Source: 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—LINEAGE® Poly Liner
Named without a submission number
—

What descends from it? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K062148Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc.2006106
K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716
K103431Coren Total Hip SystemCorentec Co., Ltd.201111
K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710
K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc.201410
K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc.20159
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240

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, K062148 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 106 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 LINEAGE® A-CLASSTM Poly Liner is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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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/K052026 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052026: Lineage a-Class Poly Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052026

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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