(70 days)
Not Found
No
The document describes a hip implant and its modifications, focusing on material, geometry, and manufacturing processes. 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 like osteoarthritis, rheumatoid arthritis, and fractures, which are therapeutic interventions.
No
This device is described as a "Femoral Stem" for hip replacement surgery, indicating it is an implant used for treatment/reconstruction rather than for diagnosing a medical condition. Its intended use is for individuals undergoing primary surgery for hip replacement due to various conditions, not for detecting or identifying those conditions.
No
The device description clearly indicates it is a physical implant (femoral stems) made of titanium alloy, 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 and fracture treatment. This is a medical device used in vivo (within the body).
- Device Description: The description details a femoral stem, which is a component of a hip implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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. . 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 (comma separated list FDA assigned to the subject device)
LZO, JDI, LWJ
Device Description
The proposed Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:
- The same indications for use
- The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
- The same materials (titanium alloy, commercially pure titanium plasma spray) .
- The same shelf life (5 years), and .
- Are packaged and sterilized using the same materials and processes (gamma ● radiation sterilization to a sterility assurance level (SAL) of 100).
This submission proposed the following design changes:
- A change to the sizing range and increments between additional femoral stem . sizes
- A heat treatment change for the additional femoral stem sizes only .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femoral
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 device to the predicate Novation Tapered 12/14 Press-Fit Femoral Stems:
- An engineering evaluation to determine that the geometric features of the ♥ proposed device correspond to the anatomical features of the femur.
- An engineering evaluation to determine that the proposed device has fatigue . strength equivalent to other comparable legally marketed femoral stems.
The results demonstrate that the proposed device is a substantially equivalent to the predicate device.
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
§ 888.3353 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.
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p. 1/2
Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness
NOV. - 8 2010.
Sponsor:
Exactech® Inc. 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
(102-487
Vladislava Zaitseva Contact: Regulatory Affairs Specialist
Date: October 12, 2010
Trade or Proprietary or Model Name(s):
Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems
Common Name:
Press-Fit Femoral Stem component
Classification Name:
- Prosthesis, hip. semi-constrained, metal/ceramic/polymer, cemented or non-● porous, uncemented. (CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Class II, Product Code LZO)
- Prosthesis, hip, semi-constrained, metal/polymer, uncemented. (CFR 888.3360 . Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Class II, Product Code LWJ)
- Prosthesis, hip, semi-constrained, metal/polymer, cemented. (CFR 888.3350. Hip joint metal/polymer semi-constrained cemented prosthesis Class II, Product Code JDI)
Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name · Manufacturer
K042842 Novation 12/14 Press-Fit Femoral Stems 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 femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also
1
102487
p.2/2
Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness
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.
Device Description:
The proposed Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:
- The same indications for use
- The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
- The same materials (titanium alloy, commercially pure titanium plasma spray) .
- The same shelf life (5 years), and .
- Are packaged and sterilized using the same materials and processes (gamma ● radiation sterilization to a sterility assurance level (SAL) of 100).
This submission proposed the following design changes:
- A change to the sizing range and increments between additional femoral stem . sizes
- A heat treatment change for the additional femoral stem sizes only .
Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Tapered 12/14 Press-Fit Femoral Stems:
- An engineering evaluation to determine that the geometric features of the ♥ proposed device correspond to the anatomical features of the femur.
- An engineering evaluation to determine that the proposed device has fatigue . strength equivalent to other comparable legally marketed femoral stems.
The results demonstrate that the proposed device is a substantially equivalent to the predicate device.
2
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 stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion 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 Northwest 66th Court Gainesville, Florida 32653
NOV - 8 2010
Re: K102487
Trade/Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI, LWJ Dated: October 12, 2010 Received: October 15, 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, Or R 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 contractly and warranties. We remind you, however, that device labeling must be truthful and not maching.
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 davice (1 https 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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Сваване вмет
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K102487
Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - Indications for Use
510(k) Number:
NOV: -- 8} 2010 :
ﻴﺔ
Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems
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 and/or (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)
K102487 Barbara Buend
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K102487