510(k) Report

510(k) · Cleared

Cleared

RX90 Low Profile Acetabular System

K042989510(k) TraditionalCleared Apr 28, 2005181-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 Apr 28, 2005 as substantially equivalent to K920639 (Biomet, Inc., 1992) and 3 other predicates after a 181-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.

Decided
Apr 28, 2005
Review
181 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K854046 (1985). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors2000: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1995: 3 other ancestors1994: 6 other ancestors1996: 1 other ancestor1986: 1 other ancestor2005: 1 descendant clearedK854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 1985K960303 · Fenning Femoral Component · Biomet, Inc. · 1996K030055 · Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components · Biomet, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 9 other ancestors3 generations back: 9 other ancestors 1 generation forward: 1 descendant K030055 · Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components · Biomet, Inc. · 2003 · recalledK960303 · Fenning Femoral Component · Biomet, Inc. · 1996K854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 19850
  1. Root · 3 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
  2. 2 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
  3. 1 generation backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
  4. This deviceK042989 RX90 Low Profile Acetabular SystemBiomet, Inc. · 2005
  5. Descendant · cites it directly · 0 of its ownK052255 Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K854046Conical Collar Hip ProsthesisKirschner Medical Corp.1985—
−2K960303Fenning Femoral ComponentBiomet, Inc.1996—
−1K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…Biomet, Inc.20033
0 (this device)K042989RX90 Low Profile Acetabular SystemBiomet, Inc.2005—
+1K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199220
199310
199460
199530
199610
199720
199810
199920
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K042989, 1985–2005Source: 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 24.3 · 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? (4)

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
*K920639RX 90 Acetabular Component System
Summary page 1
…ich Substantial equivalent to Biomet Rx9O TM Low Profile Acetabular System is substantially products cleared through the following 510(k) submissions: K920639 Rx90'~' Acetabular Component System K926107 ArCom® Acetabular Liners and Components Total…
Biomet, Inc.1992—
*K926107Arcom Polyethylene Acetabular Liners & Components
Summary page 1
…Profile Acetabular System is substantially products cleared through the following 510(k) submissions: K920639 Rx90'~' Acetabular Component System K926107 ArCom® Acetabular Liners and Components Total K(030055 Expanded indications for Non-Cemented…
Biomet, Inc.1993—
*K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…
Summary page 1
…(k) submissions: K920639 Rx90'~' Acetabular Component System K926107 ArCom® Acetabular Liners and Components Total K(030055 Expanded indications for Non-Cemented Porous Coated Hip Prostheses…
Biomet, Inc.20033
*K023357Arcpm 1050 Resin-Hips
Summary page 1
…cations for Non-Cemented Porous Coated Hip Prostheses Resin) K(023357 ArComO Polyethylene Liners and Components (1050 System is a me…
Biomet Orthopedics, Inc.20021

Also cleared against K920639: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050

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?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
  • 3 of the 24 ancestors have a recall of any class.
  • Of its descendants, K052255 (Biomet, Inc., 2005) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K920639.

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?

Rx90TM Low Profile Acetabular Shells are intended for cemented or non-cemented total hip replacement in cases of 1. Non-Inflammatory degenerative Joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques -' 5. Revision of previously…

Read the full statement (254 words)

Rx90TM Low Profile Acetabular Shells are intended for cemented or non-cemented total hip replacement in cases of

1. Non-Inflammatory degenerative Joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis

3. Correction functional deformity

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques -'

5. Revision of previously failed total hip arthroplasty.

Specific indications for compatible components that can be used with the above acetabular shells include:

Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)

9. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis

10. Correction of varus, valgus or post traumatic deformity

11. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

12. Ligament deficiencies

13. Tumor resections

14. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

15. Revision of previously failed total joint replacement

16. Trauma

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)

The FreedomTM Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, Joint or bone loss, soft laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. (K030047)

Indications for use as stated in the FDA summary.

Also cleared against K920639

1 other device cites the same predicate.

  • K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 20021 recall

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/K042989 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042989: RX90 Low Profile Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042989

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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