(26 days)
Not Found
No
The summary describes a hip replacement system and new femoral head components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is indicated for use in hip replacement due to various medical conditions, including osteoarthritis, rheumatoid arthritis, and osteonecrosis, which are diseases or disorders that require treatment or amelioration.
No
This device is a hip implant, indicated for prosthetic replacement in hip conditions and fractures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the addition of "femoral head components," which are physical hardware implants used in hip replacement surgery. The performance studies also focus on "femoral stem components," further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (hip replacement) and the conditions it treats (osteoarthritis, rheumatoid arthritis, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a component of a hip replacement system (femoral head). This is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. 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.
Product codes
LZ0
Device Description
Exactech 12/14 Alumina Femoral Heads
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 Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Exactech
JUL 1 9 2005
(352) - 377 - 1140 Phone: (352) - 378 - 2617 Fax:
FDA Establishment Number 1038671
Bennie Gladdish Contact: Hip Systems Manager/Principal Engineer
June 20, 2005 Date:
Rev. 06/20/05
Section 4 Page 1 of 2
1
page of
2526 NW 66TH COURT
GAINESVILLE, FL 3265
Exactech® AcuMatch 12/14 Press-Fit Femoral Stems
510(k) Summary of Safety and Effectiveness Special 510(k)
Trade or proprietary or model name(s):
Exactech 12/14 Alumina Femoral Heads
Information on devices to which substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| #K032964 | Exactech 12/14 Alumina Femoral Heads | Exactech, Inc. |
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 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.
Special 510(k) Modifications
- Addition of 36 mm outside diameter size femoral head components in three different . head lengths (-3.5, 0 +3.5 mm)
Conclusion:
Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.
Rev. 06/20/05
Section 4 Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
Public Health Service
JUL 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K051682
Trade/Device Name: Exactech 12/14 Alumina Femoral Heads 36 mm 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: LZ0 Dated: June 20, 2005 Received: June 23, 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
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Page 2 - Ms. 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. ・。 ﺘﺸﺘﺮ ﺗﺤ
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/dsma/dsmamain.html
Sincerely yours.
Signature
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech®, Inc.
Exactech 12/14 Alumina Femoral Heads 36 mm
Indications for Use
1081682
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.
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.
Prescription Use
X =
or
Over the Counter Use $\mu_2$
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Dental and Restorative | ||
| and Neurological Devices | ||
| K051682 | ||
| 06/20/05 | Section | |
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