(30 days)
No
The summary describes a hip implant device and its modifications, focusing on material, manufacturing process (additive manufacturing), and mechanical/biological performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is indicated for use in hip replacement due to various medical conditions affecting the hip, such as osteoarthritis and rheumatoid arthritis, and aims to restore mobility, indicating it is intended to provide a therapeutic benefit.
No
Explanation: This device is an implantable hip system used for replacement due to various hip conditions, not for diagnosing them. It is a treatment device.
No
The device description clearly indicates it is a physical medical device (acetabular shells) made from titanium alloy using additive manufacturing. The performance studies involve engineering analyses and an animal study, which are typical for hardware devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (acetabular shells) made of titanium alloy, designed for surgical implantation.
- Performance Studies: The performance studies focus on the mechanical properties of the implant and its biological fixation in an animal model, which are relevant to the safety and efficacy of a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of 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 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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes
LPH, JDI, KWZ, LZO
Device Description
The proposed Novation Crown Cup with InteGrip acetabular shells are modifications to the Novation Crown Cup Acetabular Shell, Cluster Hole, Plasma Coated devices cleared through premarket notification #K070479, Novation Crown Cup and Liners.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (5 years) ●
- . Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°).
This submission proposes the following design change:
The proposed device will have a porous surface and will be manufactured from titanium alloy per ISO 5832-3 using an additive manufacturing process. The same material surface/coating was previously cleared for porous uncemented use in the hip in 510(k) K101761 - Exactech Novation Empire Acetabular Augments with InteGrip.
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)
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Crown Cup acetabular shells:
- Abrasion resistance (ASTM F1978-07), shear fatigue strength (ASTM F1160-50), . static shear strength (ASTM F1044-08), static tensile strength (ASTM F1147-05) and compressive deformation testing was conducted to evaluate the integrity of the porous surface/coating.
- . Testing was performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 (i.e., volume % porosity [ASTM F1854-01]. pore size [ASTM F1854-01], thickness (ASTM F1854-01], interconnected porosity) for a porous-coated uncemented hip prosthesis.
- . A 12-week ovine animal study to indicate that stable fixation occurs via biological fixation and is comparable to predicate devices.
These engineering analyses were originally provided and reviewed in premarket notification K101761 - Exactech Novation Empire Acetabular Augments with InteGrip. The results of engineering analyses demonstrate the proposed device is . substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Exactech® Novation® Crown Cup® with InteGrip™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
NOV - 5 2010
(102975
| Sponsor: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
| ---------- | ----------------------------------------------------------------- |
|---|
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
- Contact: Vladislava Zaitseva Regulatory Affairs Specialist
Date: November 5, 2010
Trade of Proprietary or Model Name(s):
Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell
Common Name:
Total Hip Arthroplasty - Acetabular Components
Classification Name:
21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Class II. Product Code: LPH - prosthesis, hip, semiconstrained, metal/polymer, porous, uncemented.
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade of Proprietary Model Name | Manufacturer |
|---|---|---|
| K070479 | Novation® Crown Cup™ and Liners | Exactech, Inc |
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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
1
Exactech® Novation® Crown Cup® with InteGrip™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Device Description:
The proposed Novation Crown Cup with InteGrip acetabular shells are modifications to the Novation Crown Cup Acetabular Shell, Cluster Hole, Plasma Coated devices cleared through premarket notification #K070479, Novation Crown Cup and Liners.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (5 years) ●
- . Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°).
This submission proposes the following design change:
The proposed device will have a porous surface and will be manufactured from titanium alloy per ISO 5832-3 using an additive manufacturing process. The same material surface/coating was previously cleared for porous uncemented use in the hip in 510(k) K101761 - Exactech Novation Empire Acetabular Augments with InteGrip.
Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Crown Cup acetabular shells:
- Abrasion resistance (ASTM F1978-07), shear fatigue strength (ASTM F1160-50), . static shear strength (ASTM F1044-08), static tensile strength (ASTM F1147-05) and compressive deformation testing was conducted to evaluate the integrity of the porous surface/coating.
- . Testing was performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 (i.e., volume % porosity [ASTM F1854-01]. pore size [ASTM F1854-01], thickness (ASTM F1854-01], interconnected porosity) for a porous-coated uncemented hip prosthesis.
- . A 12-week ovine animal study to indicate that stable fixation occurs via biological fixation and is comparable to predicate devices.
These engineering analyses were originally provided and reviewed in premarket notification K101761 - Exactech Novation Empire Acetabular Augments with InteGrip. The results of engineering analyses demonstrate the proposed device is . substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
NOV - 5 2010
Re: K102975
Trade/Device Name: Exactech Novation Crown Cup with InteGrip Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, JDI, KWZ, LZO Dated: October 5, 2010 Received: October 6, 2010
Dear Ms. Zaitseva:
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. Please note: CDRH 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
3
Page 2 - Ms. Vladislava Zaitseva
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mark M. Milleson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech® Novation® Crown Cup® with InteGrip" Special 510(k) - Indications for Use
510(k) Number: K102975
NOV - 5 2010
Device Name: Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell
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.
- 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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
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)
Oputu for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102975