510(k) Report

510(k) · Cleared

Cleared

Rim Flare Acetabular Component

K955033510(k) TraditionalCleared Jan 31, 199690-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

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

Cleared on Jan 31, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 328 later devices descend from it.

Decided
Jan 31, 1996
Review
90 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2020: 18 descendants cleared2000: 1 descendant cleared2025: 24 descendants cleared2002: 2 descendants cleared2006: 6 descendants cleared2023: 20 descendants cleared2022: 23 descendants cleared2013: 22 descendants cleared2010: 8 descendants cleared2005: 1 descendant cleared2004: 2 descendants cleared2011: 21 descendants cleared2008: 7 descendants cleared2009: 6 descendants cleared2016: 15 descendants cleared2019: 18 descendants cleared2007: 1 descendant cleared2018: 18 descendants cleared2017: 17 descendants cleared2014: 10 descendants cleared2012: 22 descendants cleared2015: 10 descendants cleared2021: 20 descendants cleared2024: 16 descendants cleared2026: 19 descendants cleared1995200020052010201520202025
  1. This deviceK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. Descendant · cites it directly · 327 of its ownK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. Descendant · 2 generations on · 326 of its ownK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. Descendant · 3 generations on · 285 of its ownK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. Descendant · 4 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. Descendant · 4 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled

Showing 5 of 328 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12002: 22004: 22005: 12006: 62007: 12008: 72009: 62010: 82011: 212012: 222013: 222014: 102015: 102016: 152017: 172018: 182019: 182020: 182021: 202022: 232023: 202024: 162025: 242026: 19
1999high 24 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 328 · See all
  • K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999 · cites it directly327descendants
  • K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · 2 generations on326descendants
  • K022902Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002 · 3 generations on285descendants
  • K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 4 generations on267descendants
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 4 generations on198descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
+1K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
+2K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
+3K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
+4K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+4K042344Excia Total Hip SystemAesculap, Inc.200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200220
200420
200510
200660
200710
200870
200960
201080
2011210
2012220
2013220
2014100
2015100
2016150
2017170
2018180
2019180
2020180
2021200
2022230
2023200
2024160
2025240
2026190
FIG. 1 — Lineage of K955033, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 24.2 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (328)

See all 328

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

NumberDeviceApplicantDecidedDescendants
K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999327

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, K983509 (Sulzer Orthopedics, Inc., 1999) has gone furthest, with 327 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 Intermedics Orthopedics

108 FDA decisions under this applicant name. See the company

  • K970300Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
  • K970498Natural-Knee II Revision Femoral Spacer LugsIntermedics Orthopedics · 1997
  • K970166Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997
  • K970567Select Shoulder Curved-Back Pegged All Poly GlenoidsIntermedics Orthopedics · 1997
  • K964357Natural-Hip System Cocr StemIntermedics Orthopedics · 1997

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/K955033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955033: Rim Flare Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955033

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026