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K Number
K111039
Device Name
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
Manufacturer
ZIMMER, INC.
Date Cleared
2011-05-19

(35 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Special
Panel
OR
Reference & Predicate Devices
K040593,K042598,K043227,K043560,K050121,K051098
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, and
  • . Malunions
Device Description

The Zimmer Periarticular Locking Plate System is a plate and screw system. The low-profile periarticular plates are anatomically contoured with threaded holes to engage and "lock" the screws at a fixed angle relative to the plate.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that a device (specifically, an AI/analytic model) meets those criteria. The document is a 510(k) summary for the Zimmer Periarticular Locking Plate System, which is a physical medical device (a plate and screw system for bone fixation).

The document discusses:

  • Device Description: A plate and screw system for bone fixation.
  • Intended Use: Temporary internal fixation and stabilization of osteotomies and fractures.
  • Comparison to Predicate Device: The submission is to add a sterile version of existing non-sterile devices.
  • Performance Data (Nonclinical):
    • Sterilization Validation (terminal sterilization to SAL greater than or equal to 10-6 at 20kGy gamma dose).
    • Shelf Life (10 years, based on accelerated aging).
    • Sterile Packaging (to withstand normal distribution and storage and maintain sterile barrier).
  • Clinical Data: Stated that "Clinical data and conclusions were not needed for this device."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/analytic model, as the document is about a hardware device and does not involve AI or analytical performance testing with ground truth, expert review, or statistical measures like sample size, effect size, etc.

§ 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.