# K954800: Apr Hip Sys W/Cal-Coated Can STR Titanium (Csti)

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Apr 25, 1996 after 211 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- 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) Intermedics Orthopedics APR II and APR II-T with CSTi: named in the summary without a submission number
- (no number) Intermedics APR and APR II with Calcitite Coating: named in the summary without a submission number
- (no number) Howmedica Precision Osteolock: named in the summary without a submission number
- (no number) Osteonics Omnifit with HA: named in the summary without a submission number

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1135-2105: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is con

## Indications for use
The APR Hip System with Calcitite-Coated CSTi is indicated for noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of Inflammatory Joint Disease (e.g., rheumasoid arthritis) or Noninflammatory Degenerative Joint Disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, fracture dislocation of the hip and femoral neck fracture).

Source page: https://510kreport.com/device/K954800
Methodology: https://510kreport.com/methodology