(275 days)
Not Found
No
The summary describes a hip implant component made of a new ceramic material. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a component of a hip replacement system, indicated for use in surgical treatment of various hip conditions, which implies it is used to treat or alleviate a medical condition.
No.
The device is a component of a hip replacement system, indicated for surgical implantation, not for diagnosing conditions.
No
The device description clearly states it is a physical component (femoral heads) made of ceramic material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The provided text clearly describes a femoral head, which is a component of a hip replacement system. This device is implanted into the human body during surgery to replace a damaged hip joint.
- Lack of Specimen Examination: The device does not interact with or examine specimens (like blood, urine, tissue) outside of the body. Its function is mechanical replacement within the body.
Therefore, based on the provided information, the Exactech Hip System components, including the Ziramic™ Zirconia Femoral Heads, are implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH
Device Description
This Special 510(k) application supports the substantial equivalency of the Ziramic™ Zirconia (Zyranox®) 12/14 Femoral Heads relative to Exactech's predicate 12/14 Alumina (BIOLOX® forte) Ceramic Femoral Heads (#K032964). The design modifications include a change in the ceramic material composition from alumina to zirconia, and the addition of +7mm and +10 mm skirted heads for the 28mm, 32 mm and 36 mm outer diameter sizes.
The proposed Ceramic Femoral Heads are composed of Morgan Advanced Ceramic's Zyranox® zirconia material and have a European 12/14 taper design. The material properties of Zyranox® are described in FDA Master File MAF-343.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
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)
Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 zirconia ceramic femoral heads would be adequate for anticipated in vivo loading when mated with Exactech titanium alloy 12/14 Femoral Stems. Based on successful results we conclude that the proposed 12/14 Ziramic™ Zirconia 12/14 Femoral Heads devices are substantially equivalent Exactech's predicate 12/14 Alumina Femoral Heads (#K032964).
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
§ 888.3353 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.
0
K050398 p1/3
NOV 1 8 2005
Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness
Sponsor: Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
(352) - 377 - 1140 Phone: Fax: (352) - 378 - 2617
FDA Establishment Number 1038671
Maritza Elias Contact: Regulatory Representative
Date: November 15, 2005
1
|K05C398r r^{2/3}
Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness
| Trade / Proprietary Name: | Exactech |
|---|---|
| Model Name: | Ziramic™ Zirconia 12/14 Femoral Head |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, |
| Metal/Ceramic/Polymer, Cemented | |
| or Non-Porous, Uncemented | |
| Product Code: | LZO, LPH |
| C.F.R. Section: | 21 CFR 888.3353, 21 CFR 888.3358 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
Legally Marketed Devices for Substantial Equivalence Comparison:
Exactech 12/14 Alumina Ceramic Femoral Head #K032964
Device Description:
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
rev. 11/15/05
2
Koso398p%
Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness
CONTRAINDICATIONS
Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.
The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.
Exactech 12/14 Zirconia Ceramic Femoral Heads
This Special 510(k) application supports the substantial equivalency of the Ziramic™ Zirconia (Zyranox®) 12/14 Femoral Heads relative to Exactech's predicate 12/14 Alumina (BIOLOX® forte) Ceramic Femoral Heads (#K032964). The design modifications include a change in the ceramic material composition from alumina to zirconia, and the addition of +7mm and +10 mm skirted heads for the 28mm, 32 mm and 36 mm outer diameter sizes.
The proposed Ceramic Femoral Heads are composed of Morgan Advanced Ceramic's Zyranox® zirconia material and have a European 12/14 taper design. The material properties of Zyranox® are described in FDA Master File MAF-343.
Conclusion:
Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 zirconia ceramic femoral heads would be adequate for anticipated in vivo loading when mated with Exactech titanium alloy 12/14 Femoral Stems. Based on successful results we conclude that the proposed 12/14 Ziramic™ Zirconia 12/14 Femoral Heads devices are substantially equivalent Exactech's predicate 12/14 Alumina Femoral Heads (#K032964).
rev. 11/15/05
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2005
Maritza Elias Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K050398
Trade/Device Name: Exactech Ziramic™ Zirconia 12/14 Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LPH Dated: October 28, 2005 Received: November 1, 2005
Dear Ms. Elias:
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.
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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2- Maritza Elias
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech®, Inc. Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) - Indication for Use
510(k) Number: ---- KC50398
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
CONTRAINDICATIONS
Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, · in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.
The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.
Prescription Use
Or Over the Counter Use
Please do not write below this line - use another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Mark A. Milliken
(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative, Division rological Devices
510(k) Number
Section 3 Page 1 of 1
rev. 10/25/05