# K183129: Medtronic Total Hip Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: Jul 26, 2019 after 255 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: 6 generations back to K935452 (1994). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163585: Responsive Orthopedics Total Hip Arthroplasty System, Responsive Orthopedics, LLC (2017) Summary page 4.

## Indications for use
The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.

Source page: https://510kreport.com/device/K183129
Methodology: https://510kreport.com/methodology