# K083654: Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V Alloy, CP Grade Titanium)

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Feb 26, 2009 after 78 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000684 (2000). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063303: Universal Locking System, 2.7MM Plates & Screws, Zimmer, Inc. (2006) Summary page 1.

## Most influential descendants
- K102845: Mahe Fixation Plate and Screw System (2011), 8 descendants of its own
- K172943: Flex-Thread Fibula Pin System (2017), 4 descendants of its own
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System (2021), 3 descendants of its own
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (2018), 2 descendants of its own
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (2012), 2 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).
- 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/K083654
Methodology: https://510kreport.com/methodology