# K092561: Rejuvenate Modular Stem

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 20, 2009 after 60 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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: 1 generation back to K071082 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071082: Stryker Modular Hip System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K081044: Rejuvenate Modular Hip System, Howmedica Osteonics Corp. (2008) Summary page 2.

## Recalls of this device
- Apr 30, 2012 · Class II · Z-2090-2012: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions 

## Indications for use
The indications for use of total hip replacement prostheses include: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This hip is intended for cementless use only.

Source page: https://510kreport.com/device/K092561
Methodology: https://510kreport.com/methodology