510(k) Report

510(k) · Cleared

Cleared

A-B Acetabular Component

K954417510(k) TraditionalCleared Dec 11, 199581-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

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

Cleared on Dec 11, 1995 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 481 later devices descend from it.

Decided
Dec 11, 1995
Review
81 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2019: 34 descendants cleared2005: 5 descendants cleared2006: 2 descendants cleared2012: 19 descendants cleared2016: 26 descendants cleared2011: 12 descendants cleared2007: 4 descendants cleared2009: 6 descendants cleared2008: 3 descendants cleared2010: 6 descendants cleared2015: 22 descendants cleared2018: 26 descendants cleared2025: 38 descendants cleared2014: 29 descendants cleared2013: 30 descendants cleared2024: 34 descendants cleared2020: 32 descendants cleared2022: 34 descendants cleared2017: 21 descendants cleared2021: 31 descendants cleared2026: 34 descendants cleared2023: 32 descendants cleared1995200020052010201520202025
  1. This deviceK954417 A-B Acetabular ComponentBiomet, Inc. · 1995
  2. Descendant · cites it directly · 480 of its ownK023357 Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  4. Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  5. Descendant · 4 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  6. Descendant · 2 generations on · 289 of its ownK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005

Showing 5 of 481 descendants. See all descendants

Descendants cleared per year

2002: 12005: 52006: 22007: 42008: 32009: 62010: 62011: 122012: 192013: 302014: 292015: 222016: 262017: 212018: 262019: 342020: 322021: 312022: 342023: 322024: 342025: 382026: 34
2002high 38 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 481 · See all
  • K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · cites it directly480descendants
  • K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 2 generations on355descendants
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
  • K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 4 generations on343descendants
  • K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005 · 2 generations on289descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954417A-B Acetabular ComponentBiomet, Inc.1995—
+1K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc.20021
+2K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
+4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
+2K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200550
200620
200740
200830
200960
201060
2011120
2012190
2013300
2014290
2015220
2016260
2017210
2018260
2019340
2020320
2021310
2022340
2023320
2024340
2025380
2026340
FIG. 1 — Lineage of K954417, 1995–2026Source: 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? (481)

See all 481

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

NumberDeviceApplicantDecidedDescendants
K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc.2002480

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, K023357 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 480 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 Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K954417 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954417: A-B Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954417

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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