# K960984: SHP Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 17, 1996 after 190 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
161 later devices descend from it; 1 cites it directly.
0 of 162 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) Rx90 Total Hip System: named in the summary without a submission number
- (no number) Centralign Precoat Hip Prosthesis: named in the summary without a submission number
- (no number) Ranawat/Burstein Cemented Primary Series: named in the summary without a submission number
- (no number) Buchalter/Fauser Femoral Component: named in the summary without a submission number
- (no number) Premise Total Hip System: named in the summary without a submission number

## Most influential descendants
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own

## Indications for use
Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.

Source page: https://510kreport.com/device/K960984
Methodology: https://510kreport.com/methodology