(29 days)
Not Found
No
The document describes a hip implant with minor design modifications and does not mention any AI or ML components or functionalities.
Yes
The device, a femoral stem for hip replacement, is used to treat medical conditions such as osteoarthritis and rheumatoid arthritis, which aligns with the definition of a therapeutic device.
No
This device is a hip implant, specifically a femoral stem, used for hip replacement surgery. Its purpose is to treat conditions like osteoarthritis and fractures by replacing diseased or damaged bone, not to diagnose them.
No
The device description clearly describes a physical femoral stem implant, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a femoral stem, which is a component of a hip replacement system. This is an implantable device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use clearly states that the device is for use in skeletally mature individuals undergoing primary surgery for hip replacement due to various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a sample.
The description focuses on the physical characteristics, materials, and surgical implantation of the device, which are all consistent with a surgical implant, not an IVD.
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.
The Novation Element Press-Fit Femoral Stem is intended for press-fit fixation.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The proposed Exactech Novation Element Press-Fit Femoral Stem is a modification of the HA Coated MCS Total Hip System cleared through premarket notification #K990197 and 12/14 Acumatch Press-Fit Femoral Stem cleared through premarket notification #K041906.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- · the same indications for use
- · the same basic design features
- · incorporate the same materials
- · the same shelf life
- · are packaged and sterilized using the same materials and processes
The only modifications to the technological characteristics of the predicate devices are:
- . The trapezoidal cross-sectional geometry of the shaft has been slightly altered.
- Horizontal grooves have been added to the shaft .
Standard orthopedic instrumentation (FDA class I) is used for implantation of the Novation Element Press-Fit Femoral Stem. These press-fit femoral components are designed such that an interference condition is created between the implant and host bone.
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 verifying that the performance of the new Novation Element Press-Fit Femoral Stem is adequate for anticipated in vivo use. In addition to the design similarities listed above, these results demonstrate that the proposed device is substantially equivalent to the identified predicate 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
§ 888.3353 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
Summary of Safety and Effectiveness Special 510(k)
K08098000pg 1/3)
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
MAY - 6 2008
Contact: Xavier Sarabia Director of Regulatory Affairs
Date: April 1, 2008
1
Summary of Safety and Effectiveness Special 510(k) KOBO990 (pg 213)
Trade or proprietary or model name(s):
Novation Element Press-Fit Femoral Stem
Information on devices to which substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K990197 | HA coated MCS Total Hip System | Exactech, Inc. |
| K041906 | 12/14 Acumatch Press-Fit Femoral Stem | Exactech, Inc. |
DESCRIPTION OF DEVICE MODIFICATIONS
The proposed Exactech Novation Element Press-Fit Femoral Stem is a modification of the HA Coated MCS Total Hip System cleared through premarket notification #K990197 and 12/14 Acumatch Press-Fit Femoral Stem cleared through premarket notification #K041906.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- · the same indications for use
- · the same basic design features
- · incorporate the same materials
- · the same shelf life
- · are packaged and sterilized using the same materials and processes
The only modifications to the technological characteristics of the predicate devices are:
- . The trapezoidal cross-sectional geometry of the shaft has been slightly altered.
- Horizontal grooves have been added to the shaft .
Standard orthopedic instrumentation (FDA class I) is used for implantation of the Novation Element Press-Fit Femoral Stem. These press-fit femoral components are designed such that an interference condition is created between the implant and host bone.
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
Page 2 of 3
2
Summary of Safety and Effectiveness Special 510(k)
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.
The Novation Element Press-Fit Femoral Stem is intended for press-fit fixation.
Substantial Equivalence
Testing and engineering evaluations were conducted verifying that the performance of the new Novation Element Press-Fit Femoral Stem is adequate for anticipated in vivo use. In addition to the design similarities listed above, these results demonstrate that the proposed device is substantially equivalent to the identified predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, bold black outline.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Exactech® Inc. % Mr. Xavier Sarabia Director of Regulatory Affairs 2320 N.W. 66th Court Gainesville, FL 32653
MAY - 6 2008
Re: K080980
Trade/Device Name: Exactech Novation Element Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained or non porous uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: April 1, 2008 Received: April 7, 2008
Dear Mr. Sarabia:
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, Or vo and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, l'isting 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 max 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 - Mr. Xavier Sarabia
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech®, Inc.
Exactech Novation Element Press-Fit Femoral Stems
Indications for Use
KOBO980 Lag1/17 510(k) Number:
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.
Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.
Prescription Use
X
or
Over the Counter Use
Please do not write below this line
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Rl. Ogle for MKM
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K080980