510(k) · Cleared
ClearedArcomxl Polyethylene RX90 Acetabular Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 23, 2005 as substantially equivalent to K042989 (Biomet, Inc., 2005) after a 97-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Nov 23, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K854046 (1985). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- 3 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- 2 generations backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- 1 generation backK042989 RX90 Low Profile Acetabular SystemBiomet, Inc. · 2005
- This deviceK052255 Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| −3 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| −2 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| −1 | K042989 | RX90 Low Profile Acetabular System | Biomet, Inc. | 2005 | — |
| 0 (this device) | K052255 | Arcomxl Polyethylene RX90 Acetabular Liners | Biomet, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042989 | RX90 Low Profile Acetabular SystemSummary page 1…mented or uncemented prosthesis (21 CFR 888.3310) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Rx90 TM Low Profile Acetabular System (K042989) Device Description: The new device is composed of ArComXLTM with inner diameters of 28, 32, and 36mm. Intended Use: The ArComX… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 ancestors have a recall of any class.
How does its category compare?
All LPH devicesLPH 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The ArComXL TM Polyethylene Rx9O TM Low Profile Acetabular Liners are indicated for cemented or non-cemented use in cases of.
1) Non-inflammatory degenerative joint disease including osteoarthritis and
avascular necrosis
2) Rheumatoid arthritis
3) Correction of functional deformity
4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of
the proximal femur with head involvement, unmanageable by other
techniques.
5) Revision of previously failed total hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052255: Arcomxl Polyethylene RX90 Acetabular Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052255
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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