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K Number
K992462
Device Name
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
Manufacturer
HOWMEDICA OSTEONICS CORP.
Date Cleared
1999-08-13

(21 days)

Product Code
LZN
Regulation Number
878.3300
Type
Traditional
Panel
OR
Reference & Predicate Devices
K914406,K894708
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows:

For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs:

  • In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
Device Description

The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in cemented arthroplasties of the hip as determined by the physician. The Universal Distal Hole Plugs are manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2) and are available in one universal size. The Universal Distal Hole Plug is cylindrical in shape, has a rounded distal tip, and flares very slightly from the proximal to The Universal Distal Hole Plug also employs a friction-fit design which secures it in distal end. the distal hole of any commercially available Osteonics® cemented hip stem. The Universal Distal Hole Plug is assembled to the hip stem intraoperatively and inserted into the femoral canal.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Universal Distal Hole Plug), which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and study details. The document primarily describes:

  • Device Identification: Osteonics® Universal Distal Hole Plug (K992462)
  • Sponsor Information: Howmedica Osteonics Corp.
  • Classification: Surgical Mesh 21 CFR §878.3300
  • Predicate Devices: Osteonics® Omnifit® Universal Distal Cement Spacer (K914406) and Osteonics® Universal Distal Spacer (K894708)
  • Device Description: Single-use, made from PMMA or PMMA mixed with Barium Sulfate, cylindrical, rounded tip, friction-fit design to secure in the distal hole of a cemented hip stem.
  • Intended Use: For cement spacers, mid-shaft restrictors, and cement plugs in cemented hip arthroplasty, when the device is considered advantageous.
  • Technological Comparison: Substantially equivalent in material and basic mechanical function to predicate devices, but lacks fins and is available in one universal size.

The FDA's letter (pages 2-3 of the input) confirms the substantial equivalence determination but does not detail performance studies or acceptance criteria.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.