LogoFDA 510(k) Search
K Number
K040593
Device Name
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
Manufacturer
ZIMMER, INC.
Date Cleared
2004-04-12

(35 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K012114,K982732
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

  • Comminuted fractures .
  • Supracondylar fractures .
  • . Intra-articular and extra-articular condylar fractures
  • Fractures in osteopenic bone .
  • Nonunions e
  • Malunions t
Device Description

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Zimmer Periarticular Locking Plates), not an AI/ML device. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (like those involving test sets, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this document.

The document states:

  • Performance Data: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."
  • Comparison to Predicate Device: "The Zimmer Periarticular Locking Plate System has the same intended use, has similar performance characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices."

This indicates that the acceptance criteria for this device are based on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical (laboratory) performance testing, which typically includes mechanical and material testing to ensure safety and effectiveness for its stated intended use.

Since this is not an AI/ML device, the specific information requested in the prompt regarding AI/ML device performance evaluation (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in the provided text.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.