# K042989: RX90 Low Profile Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 28, 2005 after 181 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854046 (1985). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920639: RX 90 Acetabular Component System, Biomet, Inc. (1992) Summary page 1.
- K926107: Arcom Polyethylene Acetabular Liners & Components, Biomet, Inc. (1993) Summary page 1.
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 1.
- K023357: Arcpm 1050 Resin-Hips, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K052255: Arcomxl Polyethylene RX90 Acetabular Liners (2005), 0 descendants of its own

## Indications for use
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)

Source page: https://510kreport.com/device/K042989
Methodology: https://510kreport.com/methodology