(23 days)
Not Found
No
The document describes a hip replacement system and its components, focusing on materials, design features, and intended use. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for use in hip replacement due to various medical conditions, aiming to restore mobility and treat degenerative problems, which aligns with the definition of a therapeutic device.
No
This device is a hip replacement system, indicated for surgical implantation to treat various hip conditions, not for diagnosing them.
No
The device description clearly states the device is a physical implant (cups and liners made of titanium alloy) and does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is part of an "Exactech Hip System" and is used for "hip replacement" and "treatment of proximal femoral fractures." These are surgical procedures involving implantation of a prosthetic device directly into the body.
- Lack of Mention of Samples or Testing: The text does not mention any use of samples from the body or any form of diagnostic testing.
Therefore, the Novation Crown Cups and Liners, as described, are surgical implants and not In Vitro Diagnostic devices.
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, MEH, LPH
Device Description
The proposed Novation Crown CupsTM and Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:
NOVATION CROWN CUP AND LINERS
- No-Hole and Cluster Hole design options
- Shells manufactured from titanium (Ti) alloy with plasma coating and an additional hydroxylapitite (HA) coating option
- Sphere and taper inner diameter geometry .
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)
Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
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
Exactech®
K070479 Rge 3 2320 NW 66TH COURT
GAINESVILLE, FL 32653
352-377-1140 FAX 352-378-2617
Exactech® Novation Crown Cup™ and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
Exactech® Inc. Sponsor: 2320 N.W. 66" Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 | MAR 1 5 2007 |
|---|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Contact: Maritza Elias Regulatory Representative
Date: February 12, 2007
....
Section 4 Page 1 of 3
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1
Image /page/1/Picture/0 description: The image shows the word "Exactech" in a stylized font. The word is white and the background is black. There is a circle with a tail on the left side of the word, and a registered trademark symbol on the right side of the word.
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2320 NW 66TH COURT GAINESVILIE FL 32653
352-377-1141 FAX 352-378-2617
Exactech® Novation Crown Cup™ and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
Trade or proprietary or model name(s):
Novation Crown Cup and Liners
Information on devices to which substantial equivalence is claimed:
| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Number | ||
| #K993082 | AcuMatch A-Series Porous Coated Cups and Liners | Exactech, Inc. |
| #K000242 | AcuMatch A-Series Corundum Cups | Exactech, Inc. |
| #K051556 | AcuMatch A-Series GXL 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 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 Crown CupsTM and Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:
NOVATION CROWN CUP AND LINERS
- No-Hole and Cluster Hole design options
- Shells manufactured from titanium (Ti) alloy with plasma coating and an additional hydroxylapitite (HA) coating option
- Sphere and taper inner diameter geometry .
Section 4 Page 2 of 3
.
2
Exactech® Novation Crown Cup™ and Liners
352-377-1140 FAX 352-378-2617
Substantial Equivalency Conclusion:
Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
Special 510(k) - 510(k) Summary of Safety and Effectiveness
Section 4 Page 3 of 3
111 Mar 1 Dill xx 70 x 3 :
114
EXACTECH exist to inprove the political by maintaining their octivity and integendence. We to his shough innerity and commisses to sense.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2007
Exactech, Inc. % Ms. Maritza Elias Regulatory Representative 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K070479
Trade/Device Name: Novation Crown Cups and Liners 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, MEH, LPH Dated: February 12, 2007 Received: February 20, 2007
Dear Ms. Elias:
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.
4
Page 2 -- Ms. Maritza Elias
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. 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 Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara BruchuD
tor
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Novation Crown Cup™ and Liners Special 510(k) - Indications for Use
510(k) Number (if known):
Novation Crown Cup™ and Liners Device Name:
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.
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 Device Evaluation (ODE) Concurrence of CDRH, Office of (Division Sign-Off) Section 3 Division of General, Restorative, Page 1 of 1 and Neurological Devices 510(k) Num