# K961378: Delta Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 8, 1996 after 181 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K850055 (1985). 3 ancestors in all.
384 later devices descend from it; 2 cite it directly.
1 of 388 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901687: F-24 Femoral Hip Prosthesis, Med-Tek Corp. (1990) Summary page 1.
- K873797: TI-Fit Total Hip System, Richards Medical Co., Inc. (1987) Summary page 1.
- K850055: Profile Femoral Hip, Depuy, Inc. (1985) Summary page 2.
- (no number) AuFranc-Turner Type Total Hip: named in the summary without a submission number
- (no number) Charnley Type Total Hip: named in the summary without a submission number
- (no number) Miiller Type Total Hip: named in the summary without a submission number
- (no number) CLS Total Hip Replacement System: named in the summary without a submission number

## Most influential descendants
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis (1997), 363 descendants of its own
- 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
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own

## Recalls of this device
- Aug 2, 2006 · Not classified · Z-1470-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1469-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1467-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- Aug 2, 2006 · Not classified · Z-1468-06: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

## Indications for use
The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component in either 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 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/K961378
Methodology: https://510kreport.com/methodology