510(k) Report

510(k) · Cleared

Cleared

Osteolock Acetabular Shell System

K971854510(k) TraditionalCleared Jul 30, 199771-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

Howmedica Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 30, 1997 as substantially equivalent to K903362 (Howmedica Corp., 1990) and 3 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1990. 216 later devices descend from it.

Decided
Jul 30, 1997
Review
71 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K903362 (1990). 4 ancestors in all. 216 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 3 other ancestors2000: 3 descendants cleared2016: 6 descendants cleared2018: 13 descendants cleared2006: 2 descendants cleared2001: 2 descendants cleared2013: 10 descendants cleared2007: 3 descendants cleared2009: 4 descendants cleared2008: 6 descendants cleared2015: 6 descendants cleared2004: 1 descendant cleared2026: 16 descendants cleared2023: 13 descendants cleared2024: 18 descendants cleared2019: 11 descendants cleared2017: 13 descendants cleared2014: 7 descendants cleared2011: 9 descendants cleared2012: 7 descendants cleared2010: 3 descendants cleared2022: 16 descendants cleared2021: 14 descendants cleared2020: 8 descendants cleared2025: 25 descendants clearedK903362 · Osteolock (TM) Acetabular Cup · Howmedica Corp. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 17 descendants4 generations forward: 35 descendants5 generations forward: 57 descendants6 generations forward: 23 descendants7 generations forward: 26 descendants8 generations forward: 25 descendants9 generations forward: 16 descendants10 generations forward: 8 descendants K903362 · Osteolock (TM) Acetabular Cup · Howmedica Corp. · 19900+5+10
  1. Root · 1 generation backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
  2. This deviceK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
  3. Descendant · cites it directly · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  4. Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  5. Descendant · 3 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  6. Descendant · cites it directly · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000
  7. Descendant · 3 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled

Showing 5 of 216 descendants. See all descendants

Descendants cleared per year

2000: 32001: 22004: 12006: 22007: 32008: 62009: 42010: 32011: 92012: 72013: 102014: 72015: 62016: 62017: 132018: 132019: 112020: 82021: 142022: 162023: 132024: 182025: 252026: 16
2000high 25 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 216 · See all
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · cites it directly150descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
  • K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 3 generations on83descendants
  • K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · cites it directly69descendants
  • K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 3 generations on68descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903362Osteolock (TM) Acetabular CupHowmedica Corp.1990—
0 (this device)K971854Osteolock Acetabular Shell SystemHowmedica Corp.1997—
+1K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
+3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—
+1K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.2000—
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200030
200120
200410
200620
200730
200860
200940
201030
201190
201270
2013100
201470
201560
201660
2017130
2018130
2019110
202080
2021140
2022160
2023130
2024180
2025250
2026160
FIG. 1 — Lineage of K971854, 1990–2026Source: 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? (5)

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
*K903362Osteolock (TM) Acetabular Cup
Summary page 2
…nce in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Osteolock™ Acetabular Cup with Screw Holes (K903362), Vitalock® Solid Back Shells (K952397); Vitalock® Spiked Acetabular Shell (K953664); Osteolock™ CL Femoral Stem (K944592); and O…
Howmedica Corp.1990—
*K952397Vitalock Solid Backed Acetabular Shell
Summary page 2
…operational principles, and relative indications and contraindications to Howmedica's Osteolock™ Acetabular Cup with Screw Holes (K903362), Vitalock® Solid Back Shells (K952397); Vitalock® Spiked Acetabular Shell (K953664); Osteolock™ CL Femoral Stem (K944592); and Osteonics’ Arc Deposition Hip Components…
Howmedica Corp.1995—
*K953664Vitalock Spiked Acetabular Shell
Summary page 2
…ions and contraindications to Howmedica's Osteolock™ Acetabular Cup with Screw Holes (K903362), Vitalock® Solid Back Shells (K952397); Vitalock® Spiked Acetabular Shell (K953664); Osteolock™ CL Femoral Stem (K944592); and Osteonics’ Arc Deposition Hip Components. ERVIC) W 54, o 1 -/C DEPAR…
Howmedica Corp.1995—
*K944592Precision Osteolock Femoral Component
Summary page 2
…a's Osteolock™ Acetabular Cup with Screw Holes (K903362), Vitalock® Solid Back Shells (K952397); Vitalock® Spiked Acetabular Shell (K953664); Osteolock™ CL Femoral Stem (K944592); and Osteonics’ Arc Deposition Hip Components. ERVIC) W 54, o 1 -/C DEPARTMENT OF HEALTH & HUMAN SERVICES Publi…
Howmedica Corp.1995—
*—Osteonics’ Arc Deposition Hip Components
Named without a submission number
—

Also cleared against K903362: 3 other devices →

What descends from it? (216)

See all 216

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

NumberDeviceApplicantDecidedDescendants
K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000150
K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.200069
K993874Bofor Revision CoupPlus Orthopedics200065

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K001448 (Howmedica Osteonics Corp., 2000) has gone furthest, with 150 descendants of its own.
  • 3 other devices also cite its predicate K903362.

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 Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.

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

Also cleared against K903362

3 other devices cite the same predicate.

  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999
  • K981201Osteolock Acetabular CupHowmedica Corp. · 1998

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K971854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971854: Osteolock Acetabular Shell System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971854

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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