(27 days)
No
The device description and performance studies focus solely on mechanical properties and dimensional modifications of bone screws, with no mention of AI or ML.
Yes
The device, Exactech Hip Systems, is indicated for various medical conditions like osteoarthritis, rheumatoid arthritis, and osteonecrosis, which are chronic conditions that can cause pain and disability. The purpose of hip replacement surgery is to restore function, reduce pain, and improve the patient's quality of life, which are therapeutic goals.
No
The device description clearly states that the Exactech Alteon 6.5mm Bone Screws are intended for use in hip replacement procedures, specifically for mating with Exactech implants. Their function is to provide fixation, not to diagnose a condition.
No
The device description clearly states it is a bone screw, which is a physical hardware component, and the performance studies involve engineering analyses of this hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for hip replacement surgery and related procedures. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as bone screws intended to be implanted and mate with other hip implants. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
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
Device Description
The proposed Exactech Alteon 6.5mm Bone Screws represent a modification to the predicate Exactech 6.5mm Cancellous Bone Screws cleared in K993082. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between the predicate and the proposed devices are the following dimensional modifications:
-
- Deeper hex The hexagonal driver feature depth was increased by .013 inches to provide additional driver engagement when installing the screws.
-
- Tapered/lengthened shank The shank was lengthened by .016" and tapered.
-
- Thread form modification The thread form was modified to conform to the dimensions for HB 6.5 screws as outlined in ASTM F543-13.
-
- Modified tip geometry The tip distal to the screw head transitions to a smaller diameter with a smaller minor thread diameter.
-
- Self-Tapping Flutes The self-tapping flutes were lengthened to intersect one full thread.
These modifications are proposed to provide surgeons with screws that provide improved self-tapping abilities, and are easier to insert than the predicate screws.
The proposed hip screws are intended to mate with the following Exactech implants:
- . Exactech Novation Crown Cups (K070479, K100269)
- Exactech Novation Crown Cups with InteGrip (K102975) .
- Exactech InteGrip Acetabular Shells (K122798)
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)
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Exactech Alteon 6.5mm Bone Screws to the predicate Exactech 6.5mm Cancellous Bone Screws:
- . Torsional testing
- . Cadaveric evaluation
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon 6.5mm Bone Screws are substantially equivalent to the cleared Exactech 6.5mm Cancellous Bone Screws.
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.
K070479, K100269, K102975, K122798
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
Exactech® Alteon™ 6.5mm Bone Screws Special 510(k) - 510(k) Summary
JUL 2 9 2014
Sponsor:
Exactech®, Inc 2320 NW 66th Court Gainesville FL, 32653
Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
June 30, 2014 Date:
Contact Person: Thomas McNamara
Regulatory Affairs Associate Telephone: (352) 327-4994 Fax: (352) 378-2617
Exactech® Alteon™ 6.5mm Bone Screws Proprietary Name:
Bone Screw Common Name:
Classification Name:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR Section 888.3358, Class II, Product Code LPH)
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech 6.5mm Cancellous Bone Screws | Exactech, Inc | K993082 |
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 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.
1
Exactech® Alteon™ 6.5mm Bone Screws Special 510(k) - 510(k) Summary
Device Description
The proposed Exactech Alteon 6.5mm Bone Screws represent a modification to the predicate Exactech 6.5mm Cancellous Bone Screws cleared in K993082. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between the predicate and the proposed devices are the following dimensional modifications:
-
- Deeper hex The hexagonal driver feature depth was increased by .013 inches to provide additional driver engagement when installing the screws.
-
- Tapered/lengthened shank The shank was lengthened by .016" and tapered.
-
- Thread form modification The thread form was modified to conform to the dimensions for HB 6.5 screws as outlined in ASTM F543-13.
-
- Modified tip geometry The tip distal to the screw head transitions to a smaller diameter with a smaller minor thread diameter.
-
- Self-Tapping Flutes The self-tapping flutes were lengthened to intersect one full thread.
These modifications are proposed to provide surgeons with screws that provide improved self-tapping abilities, and are easier to insert than the predicate screws.
The proposed hip screws are intended to mate with the following Exactech implants:
- . Exactech Novation Crown Cups (K070479, K100269)
- Exactech Novation Crown Cups with InteGrip (K102975) .
- � Exactech InteGrip Acetabular Shells (K122798)
Testing:
:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Exactech Alteon 6.5mm Bone Screws to the predicate Exactech 6.5mm Cancellous Bone Screws:
- . Torsional testing
- . Cadaveric evaluation
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon 6.5mm Bone Screws are substantially equivalent to the cleared Exactech 6.5mm Cancellous Bone Screws.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
Exactech, Incorporated Mr. Thomas McNamara Regulatory Affairs Associate 2320 NW 66" Court Gainesville, Florida 32653
Re: K141797
Trade/Device Name: Exactech® Alteon" 6.5mm Bone Screws 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 Dated: June 30, 2014 Received: July 2, 2014
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 10 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: CDRFI 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 -- Mr. Thomas McNamara
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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K141797
Exactech® Alteon™ 6.5mm Bone Screws Special 510(k) - Indications For Use
Indications for Use
K141797 510(k) Number:
Device Name: Exactech® Alteon™ 6.5mm Bone Screw
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 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.
x x and/or Prescription Use __ (Part 21 CFR 801 Subpart D)
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)
Elizabeth 臣匠Frank -S
Division of Orthopedic Devices