(118 days)
No
The document describes a mechanical hip replacement system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing and engineering analysis.
Yes
The device, Exactech Hip Systems, is indicated for use in hip replacement due to various medical conditions like osteoarthritis, rheumatoid arthritis, and fractures, which directly addresses a disease or condition to restore mobility and function.
No
Explanation: This device is a total hip arthroplasty system, which is an implant used for hip replacement surgery. Its purpose is to replace parts of the hip joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy and UHMWPE, which are hardware. The performance studies also focus on mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in the human body for surgical replacement of hip joint components. This is an in vivo application.
- Device Description: The description details the materials and components of a total hip arthroplasty system, which are surgically implanted devices.
- 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 screening.
IVD devices are used outside the body to analyze samples. This device is a surgically implanted prosthesis.
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
LPH, LZO, LWJ, JDI, MEH
Device Description
Total Hip Arthroplasty (THA) is the replacement of the acetabular and femoral portions of the hip joint. The acetabular aspect of THA includes the replacement of a portion of the pelvis called the acetabulum with a prosthetic cup or an assembly of a modular shell and liner.
The proposed no-hole and cluster hole modular Crown Cups are manufactured from titanium allov (Ti-6A1-4V) and are available with commercially pure (CP) titanium plasma-spray coating or CP titanium plasma-spray with hydroxylapatite coating applied to the exterior. The CP titanium plasma spray provides initial mechanical fixation and bony on growth. The holes allow for the use of 6.5 mm screws that will enhance the primary fixation, if needed.
The proposed Crown Cup liners are available in cross-linked Connection GXL Ultra High Molecular Weight Polyethylene (UHMWPE) (ASTM F648) and come in neutral, lipped, lateralized +5mm, and 10 degrec face-changing lateralized +5mm configurations.
The proposed cups mate with the following devices:
- Novation Crown Cup GXL Liners (proposed -subject of this review)
- Novation Crown Cup GXL and Std, Group 3 Liner (K070479)
- Exactech Bone Screws (K993082)
The proposed liners mate with the following devices:
- Novation Crown Cup acetabular shells (proposed -subject of this review)
- Exactech CoCr Femoral Heads (#K041906, #K862334)
- Exactech Zirconia Femoral Heads (#K050398, #K060107)
- Exactech BioloxForte Alumina Femoral Heads (#K032964, #K051682)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Mechanical tests and engineering analyses were conducted to support the claim of substantial equivalence to the predicate Novation Crown Cups and Liners. A summary of these tests and analyses are as follows:
- A design rationalc and dimensional analyses compared to the predicate devices demonstrating the substantial equivalence of the proposed design.
- A testing of lever-out, push- out and torsional resistance demonstrating that the proposed worst- case scenario met the prescribed acceptance criteria. Additionally a gap analysis justified the decreased wear rates.
Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation Crown Cup and Liners are substantially equivalent to the cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K993082, K041906, K862334, K050398, K060107, K032964, K051682
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Exactech® Novation® Crown Cup® and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
- Exactech, Inc. I. Company: 2320 N.W. 66th Court Gainesville, FL 32653 MAY 2 7 2010
Phone: (352) 377-1140 Fax: (352) 378-2617
Graham L. Cuthbert, Regulatory Affairs Specialist II Contact Person:
January 22, 2010 Date:
Exactech® Novation® Crown Cup® and Liners II. Proprietary Name:
Common Name: Acctabular Components
Classification Name:
- Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (21 CFR 888.3358, . Class II, Product Code LPH)
- Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, . uncemented (21 CFR 888.3353, Class II, Product Code LZO)
- Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-. phosphate (21 CFR 888.3353, Class II, Product Code MEH)
- Prosthesis, hip, semi-constrained, metal/polymer, uncemented (21 CFR 888.3360, Class . II, Product Code LWJ)
- Prosthesis, hip, semi-constrained, metal/polymer, cemented/21 CFR 888,3350, Class II, . Product Code JDI)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.
| 510(k) Number | Trade of Proprietary Model Name | Manufacturer |
|---|---|---|
| K070479 | Novation® Crown Cup® and Liners | Exactech, Inc |
IV. Device Description:
Total Hip Arthroplasty (THA) is the replacement of the acetabular and femoral portions of the hip joint. The acetabular aspect of THA includes the replacement of a portion of the pelvis called the acetabulum with a prosthetic cup or an assembly of a modular shell and liner.
The proposed no-hole and cluster hole modular Crown Cups are manufactured from titanium allov (Ti-6A1-4V) and are available with commercially pure (CP) titanium plasma-spray coating or CP titanium plasma-spray with hydroxylapatite coating applied to the exterior. The CP titanium plasma spray provides initial mechanical fixation and bony on growth. The holes allow for the use of 6.5 mm screws that will enhance the primary fixation, if needed.
The proposed Crown Cup liners are available in cross-linked Connection GXL Ultra High Molecular Weight Polyethylene (UHMWPE) (ASTM F648) and come in neutral, lipped, lateralized +5mm, and 10 degrec face-changing lateralized +5mm configurations.
The proposed cups mate with the following devices:
Page 1 of 3
1
Exactech® Novation® Crown Cup® and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
- Novation Crown Cup GXL Liners (proposed -subject of this review) .
- Novation · Crown Cup GXL and Std, Group 3 Liner (K070479) .
- Exactech Bone Screws (K993082) ◆
The proposed liners mate with the following devices:
- Novation Crown Cup acetabular shells (proposed -subject of this review) .
- Exactech CoCr Femoral Heads (#K041906, #K862334) .
- Exactech Zirconia Femoral Heads (#K050398, #K060107) ◆
- Exactech BioloxForte Alumina Femoral Heads (#K032964, #K051682) �
V. Intended Use of the Device
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.
VI. Rationale for Substantial Equivalence
- Intended Use. The proposed Novation Crown Cups and Liners and predicate devices are . intended for use in total hip joint replacement and have identical indications for use statements.
- Materials. The proposed Novation Crown Cups and Liners and predicate devices are . composed of equivalent matcrials conforming to recognized industry standards for permanent implants. The hydroxylapatite coating is the same as described in 510(k) #K070479.
- Sterilization processes. The proposed Novation Crown Cups and Liners and predicate . devices are sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Design Features. The proposed Novation Crown Cups and Liners and predicate devices . incorporate similar design features including the apical lock mechanism.
- Performance specifications. The proposed Novation Crown Cups and Liners and predicate . devices conform to recognized performance standards for total hip replacement devices.
The proposed modifications for the cups include an addition to product scope, hemispherical overall height, elimination of the constrained liner feature and a modified cup thickness. The modifications for the liners include addition in scope of the product, hemispherical overall height, modified inner diameter (ID) chamfer, and a modified liner thickness.
VII. Summary of Non-Clinical Performance Data
Page 2 of 3
2
K100269
Exactech® Novation® Crown Cup® and Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
Mechanical tests and engineering analyses were conducted to support the claim of substantial equivalence to the predicate Novation Crown Cups and Liners. A summary of these tests and analyses are as follows:
- A design rationalc and dimensional analyses compared to the predicate devices demonstrating ● the substantial equivalence of the proposed design.
- A testing of lever-out, push- out and torsional resistance demonstrating that the proposed . worst- case scenario met the prescribed acceptance criteria. Additionally a gap analysis justified the decreased wear rates.
Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation Crown Cup and Liners are substantially equivalent to the cleared predicate devices.
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" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Exactech, Inc. % Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 N.W. 66th Court Gainesville, Florida 32653
MAY 2 7 2010
Re: K100269
Trade/Device Name: Exactech® Novation® Crown Cup® and Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prothesis Product Code: LPH, LZO, LWJ, JDI, MEH Regulatory Class: II Dated: April 26, 2010 Received: April 29, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting (reporting of medical
4
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.
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 vours.
erely yours,
For
N. M
Mark N Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: 100269
Device Name: Exactech® Novation® Crown Cup® and Liners
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 (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)
Joutu for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100269
Page 1 of