(30 days)
No
The document describes a modified hip implant and its intended use, focusing on design features, materials, and mechanical performance. 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 use in conditions like osteoarthritis and rheumatoid arthritis to replace hip joints. This fall under the definition of a therapeutic device as it treats medical conditions.
No
This device is a hip replacement system, primarily used for surgical intervention rather than diagnosing medical conditions.
No
The device description clearly describes a physical femoral stem, which is a hardware component.
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 conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral stem, a component of a hip implant. This is a physical device implanted in the body, not a reagent or instrument used to test samples outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device described is a surgical implant used in the treatment of hip conditions.
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
LZO, JDI
Device Description
The proposed Novation Cemented Plus femoral stem is a modification to the existing Novation Cemented femoral stem devices previously cleared in K052787. The proposed stem has the same general design features (collar, cement groove, and "cobra" flange) as the predicate stem. but incorporates a more trapezoidal distal geometry. Additionally, the proposed device includes 5 additional sizes (standard offset Size 10, standard and extended offset Size 12 and 14) to the scope. The proposed stems mate with previously cleared 12/14 CoCr (#K041906), Zirconia ceramic (#K060107), and Alumina ceramic (#K032964 and #K051682) femoral heads.
The predicate and proposed devices have intended use and basic fundamental scientific technology and share the following similarities:
- · the same indications for use
- · the same design features
- · incorporate the same materials
- · the same shelf life
- · are packaged and sterilized using the same materials and processes.
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
Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation Cemented Plus femoral stem is substantially equivalent to the cleared predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K041906, K060107, K032964, K051682
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Exactech® Novation® Cemented Plus Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness
Sponsor:
Exactech® Inc. 2320 N.W. 66th Court Gainesville, FL 32653
DEC 1 7 2008
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
Contact: Graham L. Cuthbert Regulatory Affairs Specialist
Date: November 14, 2008
Trade or Proprietary or Model Name(s): Exactech® Novation® Cemented Plus Femoral Stems
Common Name: Cemented Femoral Hip Prosthesis
Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, cemented
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Information on devices to which Substantial equivalence is claimed:
510(k) Number Trade or Proprietary or Model Name Manufacturer K052787 Novation® 12/14 Cemented Femoral Stems Exactech, Inc.
1
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.
Device Description:
The proposed Novation Cemented Plus femoral stem is a modification to the existing Novation Cemented femoral stem devices previously cleared in K052787. The proposed stem has the same general design features (collar, cement groove, and "cobra" flange) as the predicate stem. but incorporates a more trapezoidal distal geometry. Additionally, the proposed device includes 5 additional sizes (standard offset Size 10, standard and extended offset Size 12 and 14) to the scope. The proposed stems mate with previously cleared 12/14 CoCr (#K041906), Zirconia ceramic (#K060107), and Alumina ceramic (#K032964 and #K051682) femoral heads.
The predicate and proposed devices have intended use and basic fundamental scientific technology and share the following similarities:
- · the same indications for use
- · the same design features
- · incorporate the same materials
- · the same shelf life
- · are packaged and sterilized using the same materials and processes.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation Cemented Plus femoral stem is substantially equivalent to the cleared predicate devices.
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Exactech, Inc. % Mr. Graham L. Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
DEC 1 7 2008
Re: K083392
Trade/Device Name: Exactech® Novation® Cemented Plus 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 Dated: November 14, 2008 Received: November 17, 2008
Dear Mr. Cuthbert:
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 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
3
Page 2 - Mr. Graham L. Cuthbert
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Novation® Cemented Plus Femoral Stems Special 510(k) - Indications for Use
510(k) Number:
Device Name: Exactech® Novation® Cemented Plus Femoral Stems
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, theumatoid 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)
Mark N. Milken
(Division Sign-Off) (Division Sign-Old)
Division of General, Restorative,
Division of General, Devices Division of General Devices
510(k) Number __