510(k) Report

510(k) · Cleared

Cleared

System 12 P1 26MM Acetabular Insert

K951114510(k) TraditionalCleared Jun 16, 199598-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 Jun 16, 1995 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Jun 16, 1995
Review
98 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2016: 1 descendant cleared2011: 1 descendant cleared2026: 2 descendants cleared2013: 3 descendants cleared2017: 4 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2019: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951114 System 12 P1 26MM Acetabular InsertHowmedica Corp. · 1995
  2. Descendant · cites it directly · 18 of its ownK993352 Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999
  3. Descendant · 2 generations on · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
  4. Descendant · 3 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  5. Descendant · 4 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  6. Descendant · 4 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1999: 12011: 12012: 12013: 32016: 12017: 42018: 12019: 12022: 12023: 12024: 12025: 12026: 2
1999high 4 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 19 · See all
  • K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999 · cites it directly18descendants
  • K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · 2 generations on13descendants
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 3 generations on7descendants
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 4 generations on3descendants
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951114System 12 P1 26MM Acetabular InsertHowmedica Corp.1995—
+1K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp.1999—
+2K111546U2 Hip SystemUnited Orthopedic Corp.20111
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.2013—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201110
201210
201330
201610
201740
201810
201910
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K951114, 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
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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? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K993352Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp.199918

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, K993352 (Howmedica Osteonics Corp., 1999) has gone furthest, with 18 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 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

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  • 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/K951114 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951114: System 12 P1 26MM Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951114

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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