(51 days)
No
The summary describes changes to the material and geometry of hip replacement components. 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 primary hip replacement due to various medical conditions, aiming to restore mobility and treat hip problems, which are all therapeutic actions.
No.
The device described is a hip implant system, specifically femoral heads and neck segments, used for hip replacement surgery. Its intended use is for treating various hip conditions by replacing parts of the hip, not for diagnosing them.
No
The device description clearly details physical components (femoral heads and neck segments) made of materials like alumina, indicating it is a hardware medical device, 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a hip replacement system, including femoral heads and neck segments. These are implantable devices used in surgical procedures to replace damaged hip joints.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is to mechanically replace a joint.
Therefore, based on the provided information, the Exactech Hip System is a surgical implant, not an In Vitro Diagnostic device.
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.
AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.
Product codes
LZO, LPH
Device Description
Exactech 12/14 Alumina Femoral Heads: This Special 510(k) application supports design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design. The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design. The material properties of BIOLOX® forte are described in FDA Master Files MAF-197, MAF-746, and MAF-747.
AcuMatch M-Series 12/14 Neck Segments: This Spccial 510(k) application supports modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.
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, Hospital/Clinical setting for surgery
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 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
MAF-197, MAF-746, MAF-747, K993736, K010120
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 3 2003
2320 NW 661H COUF : GAINESVILLE, FL 32653
352-377-1140 FAX 352-378-2617
Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments
510(k) Summary of Safety and Effectiveness Special 510(k)
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Gary J. Miller Contact: Exec. V.P. of Research & Development
October 22, 2003 Date:
rev. 10/22/03
EXACTECH exist to inque the quility of included by munitive ad integendere. Ne to this through inovative ideos, high-quothy moves education and comminsent to serve.
1
Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments
510(k) Summary of Safety and Effectiveness Special 510(k)
| Trade / Proprietary Name: | Exactech |
|---|---|
| Model Name: | 12/14 Alumina Femoral Head |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, |
| Metal/Ceramic/Polymer, Cemented | |
| or Non-Porous, Uncemented | |
| Product Code: | LZO |
| C.F.R. Section: | not specified |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Trade / Proprietary Name: | Exactech AcuMatch |
|---|---|
| Model Name: | M-Series 12/14 Neck Segment |
| Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, |
| Porous, Uncemented | |
| Product Code: | LPH |
| C.F.R. Section: | 888.3358 |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Exactech Zirconia Ceramic Femoral Head | #K914574 |
|---|---|
| #K931617 | |
| Exactech AcuMatch M-Series Femoral Stems | |
| (Neck Segments) | #K010120 |
Section 4 Page 2 of 4
2
Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments
510(k) Summary of Safety and Effectiveness Special 510(k)
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.
AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.
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 and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
Exactech 12/14 Alumina Femoral Heads
This Special 510(k) application supports design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design.
The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design. The material properties of BIOLOX® forte are described in FDA Master Files MAF-197, MAF-746, and MAF-747.
3
Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments
510(k) Summary of Safety and Effectiveness Special 510(k)
AcuMatch M-Series 12/14 Neck Segments
This Spccial 510(k) application supports modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.
Conclusion:
Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Ms. Lisa Simpson Senior Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K032964 Trade/Device Name: Exactech 12/14 Alumina Femoral Head, Exactech AcuMatch M-Series 12/14 Neck Segment Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO Dated: October 22, 2003 Received: October 23, 2003
Dear Ms. Simpson:
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
5
Page 2 - Ms. Lisa Simpson
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.
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 (301) 594-4659. 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,
for Mark A. Mellema
Celia Witten, Ph.D., M.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exactech®, Inc.
Image /page/6/Picture/1 description: The image contains a hand-drawn circle with the text '#4' inside. The number 4 is written in a simple, slightly tilted style. The circle appears to be drawn with a pen or marker, and the overall image has a casual, informal look.
Exactech 12/14 Alumina Femoral Head Exactech AcuMatch M-Series 12/14 Neck Segment
Indications for Use
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.
AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Fcmoral Heads are intended to be used in press-fit and cemented applications.
CONTRAINDICATIONS
Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion 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.
Please do not write below this line - use another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Al or N Over the Counter Use
Division Sign Off
Estorative
spinal Neurological Devices
rev. 10/22/03
(k) Number
Section 3 Page 1 of 1