(88 days)
The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The Alumina Ceramic Femoral Heads are single-use devices manufactured from Al 2 O 3 . Both 28 and 32 mm diameter heads are available in three neck lengths each. The 12/14 bore of the ceramic ball mates with Zimmer titanium and cobalt-chromium alloy femoral stems having a corresponding 12/14 neck taper.
This document is a 510(k) summary for a medical device called "Alumina Ceramic Femoral Heads, 28 and 32 mm" manufactured by Zimmer, Inc. The purpose of this summary is to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device primarily relies on mechanical testing to establish equivalence rather than a study with acceptance criteria related to a specific performance metric like sensitivity or specificity often seen in AI/diagnostic device submissions.
Here's a breakdown of the requested information, where available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that mechanical testing was performed. The acceptance criteria are implicitly tied to the ability to withstand in vivo loading and equivalence to existing devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Withstand in vivo loading (as per FDA Draft Guidance) | "Test results indicate that the Alumina Ceramic Femoral Heads are capable of withstanding in vivo loading." |
| Equivalent to devices currently on the market (mechanically) | "Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "mechanical testing." This type of testing typically involves physical samples of the device, not a "test set" in the sense of patient data.
- Sample Size for Test Set: Not specified, but it would refer to the number of physical femoral heads tested, not patient data.
- Data Provenance: Not applicable in the context of mechanical testing. This is not a study using patient data from a specific country or collected retrospectively/prospectively. It's laboratory-based engineering performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. "Ground truth" in the context of this device's evaluation refers to the objective physical properties and performance under mechanical stress, not expert interpretation of patient data. The evaluation is against engineering standards and a comparison to predicate devices, not expert consensus on medical conditions.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not a diagnostic device or an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering standards and specifications for strength, durability, and other mechanical properties under simulated in vivo loading conditions, as outlined in the "FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems." The ultimate "truth" is whether the device physically performs as safely and effectively as the predicate devices under these conditions.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" as it is not an algorithm or an AI system that learns from data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As explained above, there is no "training set" for this device.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, stylized "Z" inside of a circle on the left, and the word "zimmer" in bold, sans-serif font on the right. The logo is black and white.
JUN - 3 2003
Summary of Safety and Effectiveness
030724
page 1 of 2
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Karen CainManager, Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605 |
| Date: | March 3, 2003 |
| Trade Name: | Alumina Ceramic Femoral Heads, 28 and 32 mm |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Nameand Reference: | Hip joint metal/ceramic/polymer semiconstrainedcemented or nonporous uncemented prosthesis21 CFR § 888.3353 |
| Predicate Devices: | Zimmer Ceramic Femoral Heads, K905739 andK914676, cleared March 7, 1991, and January 13,1992, respectively. |
| Device Description: | The Alumina Ceramic Femoral Heads are single-use devices manufactured from Al 2 O 3 . Both 28 and32 mm diameter heads are available in three necklengths each. The 12/14 bore of the ceramic ballmates with Zimmer titanium and cobalt-chromiumalloy femoral stems having a corresponding 12/14neck taper. |
| Indications for Use: | The Alumina Ceramic Femoral Heads are modularcomponents designed for use in total hiparthroplasty and indicated for the following:Patients suffering from severe hip pain anddisability due to rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis, collagen disorders,avascular necrosis of the femoral head, andnonunion of previous fractures of the femur;patients with congenital hip dysplasia, protrusio |
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Image /page/1/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white and appears to be a vector graphic.
Image /page/1/Picture/2 description: The image shows handwritten text that appears to be a combination of an identifier and page information. The text "KO 30724" is written on the top line, likely serving as a document or project identifier. Below this, the text "page 2 of 2" indicates that this is the second page of a two-page document.
Comparison to Predicate Device:
Performance Data:
acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The Alumina Ceramic Femoral Heads are substantially equivalent to the femoral heads listed above as predicate devices. Both designs are intended to function as a modular femoral head component in hip arthroplasty and are manufactured from AbO3 ceramic.
Mechanical testing was performed per the FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2003
Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K030724
Trade/Device Name: Alumina Ceramic Femoral Heads, 28 and 32 mm Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO Dated: March 3, 2003 Received: March 7, 2003
Dear Ms. Cain:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
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Page 2- Ms. Karen Cain
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
R. Mark N. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO30724
510(k) Number (if known):
Device Name:
Alumina Ceramic Femoral Heads, 28 and 32 mm
Indications for Use:
The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following:
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K030724 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
Page 1 of 1
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.