(161 days)
Not Found
No
The document describes a mechanical implant for hip replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a modular acetabular cup system intended to replace a hip joint and is indicated for rehabilitating hips damaged due to various conditions like noninflammatory degenerative joint disease. This explicitly states its purpose in treating and restoring function to a diseased or damaged body part, which aligns with the definition of a therapeutic device.
No
Explanation: The provided text describes a "Trabecular Metal Modular System" which is an acetabular cup system designed to replace a hip joint. Its stated purpose is for "rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses," and for "primary or revision total hip arthorplasties." This indicates that it is a therapeutic or prosthetic device intended for treatment, not for diagnosing conditions.
No
The device description clearly states it is a modular acetabular cup system made of metal alloys and polyethylene, intended to replace a hip joint. This is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a modular acetabular cup system intended to replace a hip joint. This is an implantable medical device used in vivo (within the body) for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity associated with in vitro testing.
Therefore, the Zimmer Trabecular Metal Modular System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trabecular Metal Modular System when used with a Trilogy® Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The Trabecular Metal Modular System when used with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthorplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
This device is intended for either cemented or noncemented use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO, KWZ
Device Description
The Zimmer Trabecular Metal Modular Acetabular System is a modular acetabular cup system intended to replace a hip joint and designed to achieve biological fixation to bone without the use of bone cement; or, it may also be for cemented fixation. The system consists of a shell and polyethylene liner. The shell substrate is made from TivaniumTM Ti-6Al-4V Alloy. The outer porous material, which is metallurgically bonded to the shell substrate, is made of Trabecular Metal.
Three porous acetabular shell designs are available: one with multiple screw holes, one with cluster screw holes and one without screw holes. The shells range in diameter from 38 to 80mm in 2mm increments. The screw holes permit the use of Tivanium Ti-6Al-4V Alloy screws for immediate fixation and security. The shell incorporates a threaded polar hole to attach the cup positioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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)
Non-clinical testing was provided, including the information outlined in the FDA" Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, 4/28/94;" and, an evaluation of the device design and geometry that demonstrated that the Zimmer Trabecular Metal Modular Acetabular System met performance requirements and is as safe and effective as its predicate and this information and testing data formed the basis for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
APR 2 8 2010
Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Benjamin C. Curson, RAC Associate Project Manager, Regulatory Affairs Telephone: (574) 372-4119 Fax: (574) 372-4605 |
| Date: | April 26, 2010 |
Zimmer Trabecular Metal™ Modular Acetabular System
LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
JDI - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
KWZ - Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer
Image /page/0/Picture/11 description: The image shows a logo with the letter 'Z' inside a circle, above the word 'zimmer' in lowercase letters. The 'Z' is bold and stylized, filling most of the circle. The word 'zimmer' is in a bold, sans-serif font and is positioned directly below the circle containing the 'Z'. The overall design is simple and modern, with a focus on the letter 'Z' and the company name.
Trade Name:
Product Code / Device:
1
Page 2
April 26, 2010
.
で
| Regulation Number / Description: | 21 CFR § 888.3358 - Hip joint
metal/polymer/metal semi-constrained porous-
coated uncemented prosthesis. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 21 CFR § 888.3350 - Hip joint metal/polymer
semi-constrained cemented prosthesis |
| | 21 CFR § 888.3353 - Hip joint
metal/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis |
| | 21 CFR § 888.3310 - Hip joint metal/polymer
constrained cemented or uncemented prosthesis |
| Predicate Device: | Zimmer Trabecular MetalTM Modular Acetabular
System, manufactured by Zimmer, Inc. K021891,
cleared September 05, 2002. |
| | Trilogy® Longevity® Constrained Liner,
manufactured by Zimmer, Inx. K071718, cleared
July 13, 2007. |
| Device Description: | The Zimmer Trabecular Metal Modular Acetabular
System is a modular acetabular cup system intended
to replace a hip joint and designed to achieve
biological fixation to bone without the use of bone
cement; or, it may also be for cemented fixation.
The system consists of a shell and polyethylene
liner. The shell substrate is made from TivaniumTM
Ti-6Al-4V Alloy. The outer porous material, which
is metallurgically bonded to the shell substrate, is
made of Trabecular Metal. |
| | Three porous acetabular shell designs are available:
one with multiple screw holes, one with cluster
screw holes and one without screw holes. The
shells range in diameter from 38 to 80mm in 2mm
increments. The screw holes permit the use of
Tivanium Ti-6Al-4V Alloy screws for immediate
fixation and security. The shell incorporates a
threaded polar hole to attach the cup positioner. |
11
2
Page 3 April 26, 2010
Intended Use:
The Trabecular Metal Modular Acetabular System with a Trilogy Neutral, Elevated, Offset or Oblique Liner is indicated for primary or revision surgery for rehabilitating hips damaged as a result of Noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
The Trabecular Metal Modular Acetabular System with a Trilogy Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained components have been considered.
This device is intended for either cemented or noncemented use.
The Zimmer Trabecular Metal Modular Acetabular System incorporates the same patient contact materials, has the same intended use, and similar technological and geometric features as the legally marketed predicate devices.
Non-Clinical Performance and Conclusions:
Non-clinical testing was provided, including the information outlined in the FDA" Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, 4/28/94;" and, an evaluation of the device design and geometry that demonstrated that the Zimmer Trabecular Metal Modular Acetabular System met performance requirements and is as safe and effective as its predicate and this information and testing data formed the basis for a determination of substantial equivalence.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
APR 2 8 2010
Zimmer. Inc. % Mr. Benjamin C. Curson, RAC Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K093561
Trade/Device Name: Zimmer Trabecular Metal Modular Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO, KWZ Dated: April 26, 2010 Received: April 27, 2010
Dear Mr. Curson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Benjamin C. Curson, RAC
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Qubau hum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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