# K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 12, 1998 after 261 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941847 (1994). 6 ancestors in all.
309 later devices descend from it; 3 cite it directly.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840643: Harris-Galante Porous Total Hip Sys, Zimmer, Inc. (1984) Summary page 1.
- K964650: TCP-Coated Porocoat Aml Femoral Hip Prosthesis, Depuy, Inc. (1997) Summary page 2.
- K921308: HG Multilock Hip Prosthesis W/ TI-Nidium, Zimmer, Inc. (1994) Summary page 2.
- K972393: Inter-OP HA Porous Acetabular System (HA/Csti), Sulzer Orthopedics, Inc. (1997) Summary page 2.

## Most influential descendants
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K001277: Triflange Acetabular Cup System (2000), 213 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own

## Recalls of this device
- Sep 14, 2012 · Class II · Z-0770-2013: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded 

## Indications for use
The Harris/Galante Hip Prosthesis is designed for implantation into the human joint in total hip or hemi-hip replacement and is indicated for the following: Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-Hip Replacement: Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained,; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

Source page: https://510kreport.com/device/K980711
Methodology: https://510kreport.com/methodology