# K111447: Zimmer Periarticular Screws

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 5, 2011 after 134 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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: 4 generations back to K962616 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K142579: Zimmer Periarticular Plating System (2014), 0 descendants of its own

## Recalls of this device
- May 4, 2016 · Class II · Z-1676-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1154-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1105-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jul 22, 2014 · Class II · Z-2549-2014: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples f

## Indications for use
Temporary internal fixation devices are designed to stabilize fractures during the normal healing process.

Source page: https://510kreport.com/device/K111447
Methodology: https://510kreport.com/methodology