(30 days)
Not Found
No
The device description and intended use focus on a mechanical centralizer for hip implants, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes.
The device is used for hip replacement due to various medical conditions such as osteoarthritis, rheumatoid arthritis, and fractures. These are therapeutic indications as they treat or manage diseases and injuries.
No
The device description states its purpose is to provide central placement of cemented stems within the femoral canal during hip replacement surgery, not to diagnose a condition.
No
The device description explicitly states the device is composed of polymethylmethacrylate (PMMA) and comes in physical sizes, indicating it is a hardware component, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "centralizer" designed to aid in the placement of hip implants during surgery. It's a physical component used during a surgical procedure, not for testing bodily fluids or tissues outside the body.
- Intended Use: The intended use is for hip replacement surgery due to various conditions affecting the hip joint. This is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, this device falls under the category of a surgical implant accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals Andergoing primary surgery for hip replacement due to osteoarthritis, theumatoid 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 the surgeon as the preferrod a oning spondylitis, congenital hip dysplasia, revision of potentially marcated 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)
JDI
Device Description
The Exactech centralizers are designed to provide central placement of Exactech cemented stems within the femoral canal.
The components have three fins and a tapered post for attachment to Exactech cemented femoral components. The device is composed of polymethylmethacrylate (PMMA) and comes in sizes ranging from 7mm to 17mm in diameter.
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
Surgeon
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)
Not Found
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Exactech
2320 NW 66TH COUR GAINESVILLE, FL 3265
352-377-1140 FAX 352-378-2617
Exactech® Femoral Stem Centralizers
510(k) Summary of Safety and Effectiveness Special 510(k)
FEB 2 7 2002
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Contact: Robert Paxson Director of Engineering & Development
January 24, 2002 Date:
Section 4 Page 1 of 3
EXACTECH exists to inquove the quility of the advity ond intependence. We to this through innovative ideos, high-quoting probection and commitment to server.
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020291
Exactech® Femoral Stem Centralizers
510(k) Summary of Safety and Effectiveness Special 510(k)
Classifications / Proprietary Names:
| Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,
Cemented (Centralizer Component) |
|-----------------------|---------------------------------------------------------------------------------------|
| Product Code: | JDI |
| C.F.R. Section: | 888.3350 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer |
|---|---|
| Total Hip System | Exactech, Inc. |
| VerSys | Zimmer |
| Answer | Biomet |
Device Description:
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals Andergoing primary surgery for hip replacement due to osteoarthritis, theumatoid 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 the surgeon as the preferrod a oning spondylitis, congenital hip dysplasia, revision of potentially marcated reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
2
020291
Exactech® Femoral Stem Centralizers
510(k) Summary of Safety and Effectiveness Special 510(k)
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 L-Series unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
DESIGN
The Exactech centralizers are designed to provide central placement of Exactech cemented stems within the femoral canal.
The components have three fins and a tapered post for attachment to Exactech cemented femoral components. The device is composed of polymethylmethacrylate (PMMA) and comes in sizes ranging from 7mm to 17mm in diameter.
UTILIZATION
Selection of the centralizer component is made by the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation of the prosthesis by: 1) appropriate reading of the literature and 2) training in the operative skills and techniques required for hip arthroplasty surgeries.
SUBSTANTIAL EQUIVALENCY
The proposed Exactech Centralizers are similar in design and material specifications to other products legally marketed in the United States, most notably Exactech's predicate centralizer design cleared through premarket notification #K862234.
Section 4 Page 3 of 3
3
Image /page/3/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 image of an eagle or bird-like figure, with stylized lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Mr. Robert Paxson Director of Engineering & Development Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K020291
Trade/Device Name: Exactech® Femoral Stem Centralizer Regulation Number: 21 CFR 888.3350 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Regulatory Class: Class II Product Code: JDI Dated: January 25, 2002 Received: January 28, 2002
Dear Mr. Paxson:
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 for use stated in the encreations of 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 Erth 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. Robert Paxson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to obgin manisting of substantial equivalence of your device to a legally prematication. "The PDF Intentify of Cassification 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 and II you desire spoorte ad 10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFA Fat 607.10 for the raily, for questions on the promotion and advertising of Compliance at (301) 591-1837. First of Compliance at (301) 594-4639. Also, please note the your devices, product commonding by reference to premarket notification" (21CFR Part 807.97). regulation entitied, "Misoranaming of responsibilities under the Act may be obtained from the Division Other general information on your respender 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,
Sincerely yours,
Mark N. Melkerson
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
5
Exactech® Femoral Stem Centralizers
Indications for Use
510(k) Number:
Device Name:
Exactech® Femoral Stem Centralizer
INDICATIONS
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals All Exactech Hip Systems are manufactures for as a close of the hip, and for undergoing primary surgery for mp roplations of the hip, and for arthritis, osteonecrosis, post-traumance cophere prosthetic replacement is determined by treatment of proximal tractures was was were of Exacted Hip Systems are also
the surgeon as the preferred treatment. Components of Exactes as also the surgeon as the preferred treatment "over its hip dysplasia, revision of
entially indicated for ankylosing spondylitis, congenital his restore potentially indicated for alleytosing spondy may was and is restore mobility resulting from previous fusion,
CONTRAINDICATIONS
CONTRAINDICATIONS
Exactech Hip Systems are contraindicated in patients with active infection, patients Exactech Hip Systems are contrainciences in patiention and fixation of the prosthesis, without sufficient bone stock to anow appropriation of the hip joint, and in patients.
in neuromuscular disorders that do not allow control of the supert accty failure of in neuromuscular disorders that do not answer the surgeon to expect early failure of the whose weight, age, of activity lever would calls and one of patients with evidence of System. The E Sories in the acetabulum and/or pelvic fractures.
R. Mark N. Mellen
Division Sign-Off) Division of General, Rest rative and Neurological Devices
Please do not write below this line - use another page if needed.
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
or
Over the Counter Use
Section 3 Page 1 of 1