(26 days)
Not Found
No
The 510(k) summary describes a modified femoral stem for hip replacement, focusing on material, design, and manufacturing changes. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device, Exactech Hip Systems, is indicated for use in hip replacement due to various medical conditions like osteoarthritis and rheumatoid arthritis, which are conditions treated to relieve symptoms or improve quality of life. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is a femoral stem for hip replacement surgery, falling under orthopedic implants, not diagnostic tools. Its intended use is for treatment, not diagnosis.
No
The device description clearly states it is a modification of a physical femoral stem and describes changes to its geometry, sizing, and coating, indicating it is a hardware device.
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 device used in vivo (within the body) for hip replacement surgery. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a physical implant (femoral stem) made of materials like titanium alloy, which 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 in vitro diagnostics.
The device is a surgical implant for hip replacement.
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.
Novation® press-fit femoral stems are intended for press-fit fixation.
Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, LWJ, JDI
Device Description
The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.
The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.
The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:
- the same indications for use, .
- similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
- the same materials (titanium alloy, commercially pure titanium plasma spray and . 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 (SAL) of 10").
This Special 510(k) application supports the following design changes:
- The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
- A change to the sizing range and differential. .
- A distally "splined" model was added to the product line. .
- Change in plasma coating application area. .
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)
A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design. Based on successful completion of design control activities for the Exactech Novation 12/14 Press-Fit Plasma Femoral Stems, we propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906. Supporting verification activities include ISO 7206-8 empirical fatigue testing and engineering analyses.
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).
This is a Special 510(k) application.
§ 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
Image /page/0/Picture/0 description: The image shows the word "Exactech" in a bold, sans-serif font. To the left of the word is a stylized "C" symbol. A registered trademark symbol is located to the right of the word.
. Paper Water Ke (GAINI 5 (H) Fire 31%)
招聘, 房 日报 FAX 357 376 17617
Exactech® Novation 12/14 Press-Fit Femoral Stems
NOV - 9 2004
510(k) Summary of Safety and Effectiveness Special 510(k)
Exactech® Inc. Sponsor: 2320 N.W. 66t" Court Gainesville, Florida 32653
(352) - 377 - 1140 Phone: Fax: (352) - 378 - 2617
FDA Establishment Number 1038671
Gary J. Miller Contact: Exec. V.P. of Research & Development
October 7, 2004 Date:
Rev. 10/07/ 04
Section 4 Page 1 of 3
1
Exactech® Novation 12/14 Press-Fit Femoral Stems
510(k) Summary of Safety and Effectiveness Special 510(k)
Trade or proprietary or model name(s):
Novation 12/14 Press-Fit Plasma Femoral Stems
Information on devices to which substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| #K041906 | AcuMatch P-Series Plasma 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 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.
Novation® press-fit femoral stems are intended for press-fit fixation.
Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Device Description:
The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.
The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.
2
042842
Exactech® Novation 12/14 Press-Fit Femoral Stems
510(k) Summary of Safety and Effectiveness Special 510(k)
The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:
- the same indications for use, .
- similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
- the same materials (titanium alloy, commercially pure titanium plasma spray and . 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 (SAL) of 10").
This Special 510(k) application supports the following design changes:
- The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
- A change to the sizing range and differential. .
- A distally "splined" model was added to the product line. .
- Change in plasma coating application area. .
Substantial Equivalency Conclusion:
A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design. Based on successful completion of design control activities for the Exactech Novation 12/14 Press-Fit Plasma Femoral Stems, we propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906. Supporting verification activities include ISO 7206-8 empirical fatigue testing and engineering analyses.
Rev. 10/07/ 04
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Gary J. Miller, Ph.D. Executive Vice President of Research & Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K042842
Trade/Device Name: Novation 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis, Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Code: LZO, MEH, LWJ, JDI Dated: October 8, 2004 Received: October 14, 2004
Dear Dr. Miller:
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 for associated in the 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 r ou may, aron's reversions 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 If your de rise 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 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.
4
Page 2 - Gary J. Miller, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse of substantial equivalence of your device to a legally promance hoticated on "ceresults 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 If you desire specific arrivance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golleral milermational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mellman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech
2320 NW 6611 1 OUt GAINI:SVILLE, FL 326
52 377 1140 FAX 352 378-26 7
Exactech®, Inc.
Indications for Use
510(k) Number (if known):
0428y_
Device Name:
Novation 12/14 Press-Fit Femoral Stems
INDICATIONS FOR USE:
All Exactech Hip Systems are indicated for use in skeletally mature individuals i the Endiven in the 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 notentially 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.
Novation® press-fit femoral stems are intended for press-fit fixation.
Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Rev. 10/04/04 | 510(k) Number | K042842
K042842 | Section 3 Page 1 of 1 |
| --------------- | --------------- | -------------------- | ----------------------- |
|---|
EXACECH exist to inqrowe the quility of the activity ond integentent. We to this through incordive ieess, ligh-quolity coduction and commitment to server