# K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Mar 3, 2010 after 211 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- 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: 6 generations back to K921308 (1994). 37 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992667: ZMR Hip System-Revision Taper, Zimmer, Inc. (1999) Summary page 1.
- K031572: ZMR Hip System-XL, Models 9921, 9922 and 9923, Zimmer, Inc. (2003) Summary page 1.
- K994038: Modular Reach Hip, Biomet, Inc. (1999) Summary page 1.
- K090757: Biomet Modular Femoral Revision System, Biomet, Inc. (2009). Cleared while this submission was under review Summary page 1.
- K994126: Modular-Plus Revision Stem, Plus Orthopedics (2000) Summary page 1.
- K032709: Modular Plus Hip Stem, Plus Orthopedics (2003) Summary page 1.

## Most influential descendants
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K151739: Revision Femoral Stem (2015), 7 descendants of its own
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K191816: M-Vizion Femoral Revision System Extension (2020), 4 descendants of its own

## Recalls of this device
- Jan 10, 2017 · Class II · Z-1191-2017: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved 

## Indications for use
The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Source page: https://510kreport.com/device/K092331
Methodology: https://510kreport.com/methodology