# K053417: M-Cor Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Portland Orthopaedics Pty., Ltd.
- Decided: Jul 20, 2006 after 224 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) S-ROM Femoral Hip Stem: named in the summary without a submission number
- (no number) Apex Modular Hip: named in the summary without a submission number
- (no number) Margron Hip Replacement: named in the summary without a submission number

## Indications for use
The M-COR Modular Hip System has the following indications for use: · The patient should be skeletally mature. * The patient's condition should be due to one or more of the following: I. Osteoarthritis. 2. Rheumatoid arthritis. 3. Ankylosing spondylitis 4. Psoriatic arthritis. 5. Tumor conditions involving the upper third of the femur or of the Acetabulum 6. Old osteomyelitis - with a long infection-free period and a nornal WBC, ESR and C-reactive protein. 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Source page: https://510kreport.com/device/K053417
Methodology: https://510kreport.com/methodology