# K082527: Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 18, 2008 after 107 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000684 (2000). 2 ancestors in all.
160 later devices descend from it; 4 cite it directly.
1 of 163 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 1.

## Most influential descendants
- K112885: Zimmer Plates and Screws System Screws Only (2011), 135 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0312-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- May 4, 2016 · Class II · Z-1675-2016: 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-1104-2016: 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.
- Oct 11, 2013 · Class II · Z-1044-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Oct 11, 2013 · Class II · Z-1041-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: o Comminuted fractures o Supracondylar fractures o Extra-articular fractures o Fractures in osteopenic bone o Nonunions o Malunions

Source page: https://510kreport.com/device/K082527
Methodology: https://510kreport.com/methodology