(151 days)
Not Found
Not Found
No
The device description focuses on the material and design of a hip prosthesis, with no mention of software, algorithms, or any technology related to AI or ML. The lack of information on image processing, AI/ML terms, training/test sets, and performance metrics further supports this conclusion.
Yes
The device is a hip prosthesis, which is implanted in the body to restore function to the hip joint, inherently classifying it as a therapeutic device.
No.
The device description indicates it is a Hip Prosthesis (femoral stems) used in total hip arthroplasty, which is a therapeutic rather than a diagnostic device.
No
The device description explicitly states it consists of "femoral stems which are manufactured from forged cobalt-chrome" and are "available in a modular configuration." This clearly indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The description clearly states that the device is a "Hip Prostheses for total hip arthroplasty" consisting of "femoral stems". This is a surgically implanted device used to replace a hip joint.
- Intended Use / Indications for Use: While "Not Found" is listed, the device description strongly indicates a surgical implant for hip replacement.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not fit that description.
The device described is a medical device, specifically a surgical implant, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
The Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses for total hip arthroplasty consists of femoral stems which are manufactured from forged cobalt-chrome. They are available in a modular configuration. The femoral stems are straight and collarless. The femoral stems may be used with Zimmer femoral heads and corresponding acetabular liners and shells.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howmedica Exeter Hip and Zimmer Charnley-Type Hip
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
51α(k) 960658
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo features a stylized letter "Z" inside a circle above the word "zimmer" in a lowercase sans-serif font. The logo is black and white.
JU 16 1996
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
-
Submitted by: ●
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 -
Prepared by:
Ruth Ann Wood Senior Regulatory Affairs Associate -
Date: .
February 14, 1996 -
. Trade Names:
Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses -
Classification Name: .
Hip Joint metal/polymer semi-constrained cemented prosthesis -
Predicate Devices: .
Howmedica Exeter Hip and Zimmer Charnley-Type Hip -
Device Description: .
The Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses for total hip arthroplasty consists of femoral stems which are manufactured from forged cobalt-chrome. They are available in a modular configuration. The femoral stems are straight and collarless. The femoral stems may be used with Zimmer femoral heads and corresponding acetabular liners and shells.
Image /page/0/Picture/21 description: The image contains a number 67. The number is written in a bold, sans-serif font. The digits are slightly separated, and the overall impression is of a clear, legible numeral.