# K110555: Arcomxl Active Articulation

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 24, 2011 after 24 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 56 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101336: E1 Avantage Head, Biomet Manufacturing Corp (2011) Summary page 1.
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 2.
- K062995: M2A-Magnum Tri-Spike Acetabular Component, Biomet Manufacturing Corp (2006) Summary page 2.
- K011110: M2A Acetabular System, Biomet, Inc. (2001)
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 2.
- K991990: Tri-Polar System, Biomet, Inc. (1999) Summary page 3.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 3.

## Most influential descendants
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K170359: Trinity™ Dual Mobility System (2017), 10 descendants of its own
- K161190: G7 Dual Mobility System, Active Articulation System (2016), 7 descendants of its own
- K191831: MobiliT Cup (2020), 3 descendants of its own
- K190535: BiMobile Dual Mobility System - E-Dur Inserts (2019), 3 descendants of its own

## Recalls of this device
- Dec 19, 2016 · Class II · Z-1024-2017: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K110555
Methodology: https://510kreport.com/methodology