(127 days)
Not Found
No
The document describes a hip implant and its modifications, focusing on materials, geometry, and mechanical testing. There is no mention of AI or ML technology being used in the device itself or its function.
Yes
The device is a hip replacement system, indicated for primary hip replacement due to various conditions and for revision of failed previous reconstructions, which are considered therapeutic interventions.
No
Explanation: The device is a hip implant system, which is a therapeutic device used for joint replacement, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical implant (femoral stem) made of titanium alloy with a hydroxyapatite coating, intended for surgical implantation. It is 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 therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral stem, which is a component of a hip implant. This is a physical implant used in surgery.
- No mention of in vitro testing: The text does not describe any testing of samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Anatomical Site: The device is used within the body (hip, proximal femoral). IVDs are used to test samples taken from the body.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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)
MEH
Device Description
The proposed Exactech Novation Element Press-Fit Femoral Stems are a modification of the Exactech Novation Element Press-Fit Femoral Stems cleared through premarket notification #K080980.
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 design features (e.g. stem geometry, femoral head taper design, stem . insertion feature)
- The same materials (titanium alloy, hydroxyapatite coating) .
- 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 of 10°).
This submission proposes expanding the scope of Novation Element femoral stems by adding new components with modified neck geometry and adding alternative coating suppliers.
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
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 Element 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.
- Mechanical testing to confirm that the proposed device, under worst case . conditions, has fatigue strength equivalent to other comparable legally marketed femoral stems.
- A comparison of the HA coating characterization information of predicate and . proposed devices as outlined in the FDA guidance document "510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants".
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.
0
KI13320 (pa 112)
Exactech® Novation® Element Press-Fit Femoral Stem Special 510(k) - 510(k) Summary of Safety and Effectiveness
MAR 1 6 2012
Exactech® Inc. Sponsor: 2320 N.W. 66tt Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
Vladislava Zaitseva Contact: Regulatory Affairs Specialist
December 21, 2011 Date:
Trade or Proprietary or Model Name(s):
Exactech® Novation® Element Press-Fit Femoral Stem
Common Name:
Press-Fit Femoral Stem component
Classification Name:
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, . Calicum-Phosphate (21 CFR Section 888.3353, Class II, Product Code MEH)
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K080980 | Novation Element Press-Fit Femoral Stem | 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 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® Novation® Element Press-Fit Femoral Stem Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
The proposed Exactech Novation Element Press-Fit Femoral Stems are a modification of the Exactech Novation Element Press-Fit Femoral Stems cleared through premarket notification #K080980.
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 design features (e.g. stem geometry, femoral head taper design, stem . insertion feature)
- The same materials (titanium alloy, hydroxyapatite coating) .
- 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 of 10°).
This submission proposes expanding the scope of Novation Element femoral stems by adding new components with modified neck geometry and adding alternative coating suppliers.
Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Element 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.
- Mechanical testing to confirm that the proposed device, under worst case . conditions, has fatigue strength equivalent to other comparable legally marketed femoral stems.
- A comparison of the HA coating characterization information of predicate and . proposed devices as outlined in the FDA guidance document "510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants".
In addition to the design similarities listed above, the results demonstrate that the proposed device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, FL 32653
Re: K113320
R 113320
Trade/Device Name: Exactech® Novation® Element Press-Fit Femoral Stem 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: MEH Dated: January 24, 2012 Received: January 25, 2012
Dear Ms. Zaitseva:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becasil >10(t) presidentially equivalent (for the indications felerenced above and nave ustimansal predicate devices marketed in interstate for use stated in the encrosure) to regard annual date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassined in assess as a proval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment Act (Act) that to not require approvince in esseral controls provisions of the Act. The You may, inerelore, market the device, becjoct to me gentration, listing of
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rict meridae road prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Frease note: CDICT Good not be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) into time major regulations affecting your device can be may be subject to additional confrois: Existing may so again and to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi found in the Code of I cacal Regarations), cour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitution with other requirements of the Act
that FDA has made a determination that your device complies with of concies . You that FDA has made a decermination that Joint stered by other Federal agencies. You must or any Federal statutes and regulations administration of registration and listing (21
comply with all the Act's requirements, including, but not managering of medical comply with all the Act 3 requirements, and medical device reporting (teporting of medical
CFR Part 807); labeling (21 CFR Part 801); medical struing programs; as CFR Part 807); labeling (21 CFR 803); medical as not september +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
3
Page - 2 - Ms. Vladislava Zaitseva
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 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,
Ke Pete Thim
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® Element Press-Fit Femoral Stem Special 510(k) - Indications for Use
KI13320 (pg VI) 510(k) Number:
Device Name: Exactech® Novation® Element Press-Fit Femoral Stem
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.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit . applications.
Prescription Use and/or X (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)
De Usal
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113320