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K Number
K964951
Device Name
KINEMAX PLUS TIBIAL SPACERS
Manufacturer
HOWMEDICA CORP.
Date Cleared
1997-02-24

(76 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K915512,K884837,K872379,K915132,K922285,K896542,K901457,K903286,K914072
Predicate For
K983072
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

Device Description

There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® allov. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device (Kinemax® Plus Tibial Spacers) and does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/software-based medical devices.

The document describes:

  • Device identification: Kinemax® Plus Tibial Spacers
  • Intended use: Augmentation for tibias with bone loss in total knee replacement.
  • Device description: Three types of spacers, fabricated from cast Vitallium® alloy, with fixation screws/pegs. Sold sterile.
  • Substantial equivalence: Compares the device to other legally marketed products (listed with K numbers).
  • Contact information.

There is no mention of:

  1. A table of acceptance criteria and reported performance.
  2. Sample size, data provenance, ground truth, or expert qualifications for a test set.
  3. Adjudication methods.
  4. MRMC studies or human reader improvement with AI.
  5. Standalone algorithm performance.
  6. Type of ground truth.
  7. Training set details.

This type of 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting clinical or performance study data in the way you've outlined for AI/software devices.

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.