# K110836: CLS Brevius Stem with Kinectiv Technology

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Oct 7, 2011 after 196 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: 8 generations back to K850055 (1985). 21 ancestors in all.
No later device cites it as a predicate yet.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042249: CLS Spotorno Stem, Zimmer Austin, Inc. (2004) Summary page 2.
- K081007: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Zimmer, Inc. (2008) Summary page 2.
- K071856: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks), 7713 Series, Zimmer, Inc. (2007) Summary page 2.
- K063251: Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology, Zimmer, Inc. (2007) Summary page 2.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0319-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
Total hip replacement for patients with: a Noninflamniatory degenerative joint disease (NLDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Femoral neck fractures. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Hemi-hip replacement for patients with: Femoral neck fractures. This femoral stem is for cementless use only.

Source page: https://510kreport.com/device/K110836
Methodology: https://510kreport.com/methodology