(412 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a manufacturing process modification, not software or algorithmic changes.
Yes
The device is indicated for use in hip replacement due to various medical conditions, clearly fitting the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is a hip implant system, which is a prosthetic device used for replacement of hip joints, not a device used to diagnose medical conditions.
No
The device description and performance studies clearly indicate this is a physical medical device (hip cup) with a modified manufacturing process for its coating, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The device is described as a hip cup, a physical component used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties and coating of the implant, which are relevant to its function as a surgical device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, JDI, LWJ, MBL
Device Description
The proposed Novation Crown Cup devices represent a modification to the predicate Novation Crown Cup cleared in K070479 and K100269. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only difference between the predicate and the proposed devices is the process by which the titanium plasma spray coating is applied.
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)
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Novation Crown Cup devices to the predicate Novation Crown Cups:
- Stereological Evaluation of Porous Coating
- Tensile and Shear Testing of Porous Coating
- Abrasion Resistance Testing
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Novation Crown Cup are substantially equivalent to cleared Novation Crown Cup devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Exactech Incorporated Mr. Thomas McNamara Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653
Re: K141960 Trade/Device Name: Exactech® Novation® Crown Cup® 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, LZO, JDI, LWJ, MBL Dated: July 22, 2015 Received: July 27, 2015
Dear Mr. McNamara:
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
1
Page 2 - Mr. Thomas McNamara
(21 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K141960 510(k) Number:
Device Name: Exactech® Novation® Crown Cup®
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.
- . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
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 - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Exactech® Novation® Crown Cup® Plasma Spray Coating Manufacturing Change Traditional 510(k)
510(k) Summary
| Sponsor: | Exactech®, Inc
2320 NW 66th Court
Gainesville FL, 32653 |
|-------------------|------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Date: | August 27, 2015 |
| Contact Person: | Thomas McNamara
Regulatory Affairs Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Novation® Crown Cup® |
Common Name: Acetabular Component
Classification Name:
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or ● Non-Porous, Uncemented, 21 CFR 888.3353, Class II, Product Code LZO
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 21 CFR ● 888.3350 Class II, Product Code JDI
- Prosthesis, Hip, Semi-constrained, Meta/Polymer, Porous Uncemented, 21 ● CFR 888.3358, Class II, Product Code LPH
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, 21 CFR 888.3360, Class II, Product Code LWJ
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous, 21 ● CFR 888.3358, Class II, Product Code MBL
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech Novation Crown Cup and | ||
| Liners | Exactech, Inc | K070479, K100269 |
Indication 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
4
Exactech® Novation® Crown Cup® Plasma Spray Coating Manufacturing Change Traditional 510(k)
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.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
- Femoral heads and endoprostheses are intended for use in cemented and pressfit applications.
Device Description
The proposed Novation Crown Cup devices represent a modification to the predicate Novation Crown Cup cleared in K070479 and K100269. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only difference between the predicate and the proposed devices is the process by which the titanium plasma spray coating is applied.
Testing:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Novation Crown Cup devices to the predicate Novation Crown Cups:
- . Stereological Evaluation of Porous Coating
- Tensile and Shear Testing of Porous Coating
- Abrasion Resistance Testing .
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Novation Crown Cup are substantially equivalent to cleared Novation Crown Cup devices.