(161 days)
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.
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.
The provided documentation is a 510(k) premarket notification for a medical device, specifically the Zimmer Trabecular Metal™ Modular Acetabular System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance or efficacy through extensive clinical trials. Therefore, the information typically requested for AI/software-as-a-medical-device performance (like precision, recall, expert consensus, training/test set details, MRMC studies) is generally not present in this kind of filing.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/software device. Instead, the "acceptance criteria" for this implant are implicitly met by demonstrating substantial equivalence to predicate devices. The reported "performance" is that the device "met performance requirements and is as safe and effective as its predicate."
| Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The device was determined to be substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological/geometric features, and performs as safely and effectively. |
| Compliance with FDA Guidance Document | The device's 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;" |
| Device Design and Geometry | An evaluation of the device design and geometry demonstrated that the Zimmer Trabecular Metal Modular Acetabular System met performance requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable in the context of an AI/software performance study. The "test set" here refers to the physical device and its components undergoing non-clinical bench testing. The document does not specify a "sample size" for these non-clinical tests (e.g., number of implants tested).
- Data Provenance: Not applicable. The "data" refers to non-clinical testing results obtained from the manufactured device, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable. Ground truth, in the context of AI, usually refers to labeled data for diagnostic tasks. For a physical orthopedic implant, "ground truth" is established through engineering specifications, material science standards, and established biomechanical testing protocols, not by expert interpretation of images or clinical cases. The "experts" would be the engineers and scientists who performed and interpreted the non-clinical tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm validation to resolve discrepancies in expert labeling or diagnoses. This filing for an implant relies on objective non-clinical test results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Comparative Effectiveness Study: No. This is not an AI/software device, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this device's performance is based on engineering specifications, material science data, and established biomechanical testing standards and protocols (e.g., those referenced in the FDA Guidance Document for Orthopedic Implants). The device is deemed to perform adequately if it meets these defined engineering and material requirements.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is not an AI/software device.
In summary: K093561 is a 510(k) premarket notification for a physical medical device (hip implant). The regulatory pathway for such devices focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through non-clinical performance testing (bench testing, material characterization, design evaluation) rather than clinical studies or AI algorithm validation. Therefore, most of the requested information pertaining to AI/software performance metrics, ground truth establishment for datasets, and multi-reader studies is not relevant to this specific filing.
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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:
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April 26, 2010
.
で
| Regulation Number / Description: | 21 CFR § 888.3358 - Hip jointmetal/polymer/metal semi-constrained porous-coated uncemented prosthesis. |
|---|---|
| 21 CFR § 888.3350 - Hip joint metal/polymersemi-constrained cemented prosthesis | |
| 21 CFR § 888.3353 - Hip jointmetal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis | |
| 21 CFR § 888.3310 - Hip joint metal/polymerconstrained cemented or uncemented prosthesis | |
| Predicate Device: | Zimmer Trabecular MetalTM Modular AcetabularSystem, manufactured by Zimmer, Inc. K021891,cleared September 05, 2002. |
| Trilogy® Longevity® Constrained Liner,manufactured by Zimmer, Inx. K071718, clearedJuly 13, 2007. | |
| Device Description: | The Zimmer Trabecular Metal Modular AcetabularSystem is a modular acetabular cup system intendedto replace a hip joint and designed to achievebiological fixation to bone without the use of bonecement; or, it may also be for cemented fixation.The system consists of a shell and polyethyleneliner. The shell substrate is made from TivaniumTMTi-6Al-4V Alloy. The outer porous material, whichis metallurgically bonded to the shell substrate, ismade of Trabecular Metal. |
| Three porous acetabular shell designs are available:one with multiple screw holes, one with clusterscrew holes and one without screw holes. Theshells range in diameter from 38 to 80mm in 2mmincrements. The screw holes permit the use ofTivanium Ti-6Al-4V Alloy screws for immediatefixation and security. The shell incorporates athreaded polar hole to attach the cup positioner. |
11
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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):
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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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<093541
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Trabecular Metal™ Modular Acetabular System
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senuta for mxn
(DKision Sign-Ord Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093561
Page 1 of 1
173
§ 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.