510(k) · Cleared
Recalled · Class II · 2016Arcomxl Active Articulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 24, 2011 as substantially equivalent to K101336 (Biomet Manufacturing Corp, 2011) and 6 other predicates after a 24-day review. Its family tree reaches back 9 generations to 1981. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 24, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 9 generations to K810258 (1981). 56 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- This deviceK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011
- Descendant · cites it directly · 21 of its ownK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 10 of its ownK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK191831 MobiliT CupCorin U.S.A. Limited · 2020
- Descendant · 3 generations on · 3 of its ownK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 1 generation backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- This deviceK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · cites it directly21descendants
- K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · 2 generations on10descendants
- K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016 · cites it directly7descendants
- K191831MobiliT CupCorin U.S.A. Limited · 2020 · 3 generations on3descendants
- K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −2 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −1 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| 0 (this device) | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | — |
| +1 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| +2 | K170359 | Trinity™ Dual Mobility System | Corin U.S.A. Limited | 2017 | 1 |
| +1 | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| +3 | K191831 | MobiliT Cup | Corin U.S.A. Limited | 2020 | — |
| +3 | K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K101336 | E1 Avantage HeadSummary page 1…ct Code(s) LPH (888,3358), LZO (888.3353), KWY (888.3390) Legally marketed device(s) to which El Tm Avantage Tm Head (ElTmActive Articulation), K101336 equivalence isclaimed _______________________ ReasnSIL~k)The ArComXL' Active Articulation is only a material change… | 2011 |
| * | K042037 | M2A Magnum SystemSummary page 2…CORP been cleared in previous submissions: M2a Magnum 2TM (K042037), Magnum Tni-Spike (K062995), and M a 35TM Flared Cups and Non-Flared Cups (KO… | 2004 |
| * | K062995 | M2A-Magnum Tri-Spike Acetabular ComponentSummary page 2…been cleared in previous submissions: M2a Magnum 2TM (K042037), Magnum Tni-Spike (K062995), and M a 35TM Flared Cups and Non-Flared Cups (KOllilO).… | 2006 |
| * | K011110 | M2A Acetabular System | 2001 |
| * | K042051 | Arcomxl Polyethylene LinersSummary page 2…new material; the material and manufacturig process were cleared in K042051, ArComX Tm Polyethylene Liners, as well as subsequent submissions. The ArComXL… | 2005 |
| * | K991990 | Tri-Polar SystemSummary page 3…the Bipolar/Tni-Polar ___________ _____predicate. (K991990) Wear Testing IO122As in the ElTm Active… | 1999 |
| * | K032396 | Ringloc 36MM Line and Modular Femoral HeadsSummary page 3…ArCom Tm 36mm liners (K032396), the largest-sized, cleared ArCom… | 2003 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2016 | Class II | Z-1024-2017 | Under Investigation by firm | Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. |
| Dec 19, 2016 | Class II | Z-1025-2017 | Under Investigation by firm | Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 56 ancestors have a recall of any class.
- Of its descendants, K150522 (Biomet, Inc., 2015) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K101336.
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. 2011, this device’s year, is highlighted.
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?
1. Noninflammatory 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 using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
The ArComXL Tm Active Articulation Head is a single-use implant, intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110555: Arcomxl Active Articulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110555
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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