# K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 26, 2006 after 41 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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: 1 generation back to K000684 (2000). 1 ancestor in all.
187 later devices descend from it; 11 cite it directly.
1 of 189 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- (no number) Zimmer® ECT® Internal Fracture Fixation system: named in the summary without a submission number

## Most influential descendants
- K082527: Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws (2008), 160 descendants of its own
- K063303: Universal Locking System, 2.7MM Plates & Screws (2006), 146 descendants of its own
- 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

## 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-1673-2016: 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-1106-2016: 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.
- Dec 9, 2015 · Class II · Z-0654-2016: The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-493
- Oct 11, 2013 · Class II · Z-1042-2014: 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 Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including; * Comminuted fractures * Supracondylar fractures * Extra-articular fractures * Fractures in osteopenic bone * Nonunions * Malunions

Source page: https://510kreport.com/device/K060710
Methodology: https://510kreport.com/methodology