# K960588: Wagner Revision Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Aug 5, 1996 after 175 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
104 later devices descend from it; 3 cite it directly.
0 of 105 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) Miiller Type Proximal Femur: named in the summary without a submission number
- (no number) Proximal Third Femoral Prosthesis: named in the summary without a submission number

## Most influential descendants
- K983404: Type 3 Femoral Components (1998), 102 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K022549: Restoration Modular System (2002), 54 descendants of its own
- K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own
- K120578: Accolade II Hip Stem (2012), 46 descendants of its own

## Indications for use
This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.

Source page: https://510kreport.com/device/K960588
Methodology: https://510kreport.com/methodology