# K963109: Heritage Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 9, 1997 after 150 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Charnley-Type Total Hip Prosthesis: named in the summary without a submission number
- (no number) ZCH Hip Prosthesis: named in the summary without a submission number
- (no number) Longevity™ Monoblock Hip Prosthesis: named in the summary without a submission number

## Most influential descendants
- K982812: G2 Total Hip System Femoral Stem (11/13 Taper) (1998), 0 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-1168-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Oct 11, 2013 · Class II · Z-1029-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Aug 28, 2013 · Class II · Z-0277-2014: Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previousl

## Indications for use
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures. The indications for total hip arthroplasty are: 1. Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. 2. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. 3. Patients suffering from disability due to previous fusion. 4. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. 5. Patients with acute femoral neck fractures. The indications for hemi-hip arthroplasty are: 1. Fracture dislocation of the hip. 2. Elderly, debilitated patients when a total hip replacement is contraindicated. 3. Irreducible fractures in which adequate fixation cannot be obtained. 4. Certain high subcapital fractures and comminuted femoral fractures in the aged. 5. Nonunion of femoral neck fractures. 6. Secondary avascular necrosis of the femoral head. 7. Pathological fractures of the femoral neck. 8. Osteoarthritis in which the femoral head is primarily affected.

Source page: https://510kreport.com/device/K963109
Methodology: https://510kreport.com/methodology