(126 days)
Not Found
No
The summary describes a traditional medical device (femoral stem hip system) and its testing, with no mention of AI or ML capabilities.
Yes
The device is a hip replacement system intended to treat various degenerative joint diseases, correct deformities, and address failed treatments or fractures, which are all therapeutic interventions aimed at restoring function or alleviating symptoms.
No
Explanation: The device is a femoral stem hip system intended for total or hemi hip replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "Femoral Stem Hip System" and describes physical components like "femoral stems" and "femoral heads" made of specific materials. The performance studies also focus on physical properties like fatigue and range of motion, not software performance.
No, 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: The provided text describes a femoral stem hip system, which is an implantable device used in hip replacement surgery. It is a physical component inserted into the body.
- Intended Use: The intended use is for total or hemi hip replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Exeter® V40™ Femoral Stem Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.
The Exeter® V40TM Femoral Stem Hip System is indicated for:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · rheumatoid arthritis:
- · correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
JDG, JDI, KWY, LZO
Device Description
The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:
- 0 Range of Motion Analysis
- Femoral Stem Neck and Body Fatigue, ISO 7206-4 (2010)and ISO 7206-6 (2013) o
- Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 and European 0 Pharmacopoeia Chapter 2.6.14 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Stryker Orthopaedics Kirsten Lehmuller Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
March 19, 2018
Re: K173499
Trade/Device Name: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDG, JDI, KWY, LZO Dated: February 16, 2018 Received: February 20, 2018
Dear Kirsten Lehmuller:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173499
Device Name
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Indications for Use (Describe)
Exeter® V40TM Femoral Stem Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.
The Exeter® V40TM Femoral Stem Hip System is indicated for:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · rheumatoid arthritis:
- · correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kirsten Lehmuller
Staff Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
201-831-5903 |
| Alternate Contact | Kristen Meany
Sr. Regulatory Affairs Manager
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
201-972-9164 |
| Date Prepared: | November 9, 2017 |
| Proprietary Name: | Exeter® V40™ Femoral Stem Hip System |
| Common Name: | Artificial Hip Replacement |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis 21 CFR §888.3353 |
| | Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR
§888.3350 |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis 21 CFR §888.3360 |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis 21 CFR §888.3390 |
| Product Codes: | JDI, LZO, JDG, KWY |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Exeter V40 Femoral Stems – K011623, K110290, K121308, K153345
Accolade HFx Femoral Stems - K051741, K121308
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Biomet Sirius Femoral Hip Stem - K130610, K142295
Device Description: The Exeter® V40™ Femoral Stems/Orthinox Femoral Heads are sterile, single-use components intended for cemented total and hemi-hip arthroplasty. The femoral stems have a tapered distal portion with a V40™ neck taper. The stems are available in various offsets and body sizer. The Exeter Hip System continues to be manufactured from the same materials, the same design and the same manufacturing process as the previously cleared Exeter® V40™ femoral stems.
Intended Use: The subject devices are intended for use in total or hemi hip arthroplasty. The subject devices are intended for cemented use only.
Indications: Exeter® V40™ Femoral Stem Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.
The Exeter® V40TM Femoral Stem Hip System is indicated for:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
- rheumatoid arthritis:
- · correction of functional deformity;
- · revision procedures where other treatments or devices have failed; and,
- · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Summary of Technological Characteristics: The technological characteristics (material, design, and operational principles) of the Exeter® V40™ Hip System are similar or identical to the predicate devices. The purpose of this submission is to introduce additional stem lengths to the Exeter V40 Hip System that are within the cleared stem lengths range, add additional Orthinox femoral heads, and update compatibility for compatible usage with unipolar and bipolar femoral heads.
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:
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- 0 Range of Motion Analysis
- Femoral Stem Neck and Body Fatigue, ISO 7206-4 (2010)and ISO 7206-6 (2013) o
- Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 and European 0 Pharmacopoeia Chapter 2.6.14 was used for pyrogenicity testing to achieve an Endotoxin limit of