(238 days)
No
The summary describes a traditional hip stem implant and its mechanical testing, with no mention of AI or ML.
Yes
The device is a hip stem intended for use in total hip replacement, which is a medical procedure to treat conditions like osteoarthritis, avascular necrosis, and fractures, aiming to restore function and alleviate pain. This qualifies it as a therapeutic device.
No
The document describes a hip stem intended for use in total hip replacement, clearly defining its purpose as a medical implant for treating joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly states it is a hip stem, which is a physical implant used in total hip replacement. The performance studies also describe physical testing of the device and its components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "total hip replacement" and is a "hip stem." This is a surgical implant used in the body, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a "hip stem" made of stainless steel, a physical implant.
- Anatomical Site: The anatomical site is the "Hip joint, proximal femur," which is within the human body.
- Performance Studies: The performance studies focus on mechanical testing of the implant (axial pull-off, fatigue, compression, galvanic corrosion, fretting), not on analyzing biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is a prosthetic implant for surgical use.
N/A
Intended Use / Indications for Use
The Exeter® hip is intended for use in total hip arthroplasty. They are intended for cemented use only. The Exeter® hip is provided sterile for single-use.
The Exeter® Femoral Stems are currently cleared for use with femoral heads manufactured from Zirconia, alumina ceramic, Biolox® delta ceramic, and stainless steel. The purpose of this 510(k) is that the Exeter® stems will now be marketed as compatible with Howmedica Osteonics' V40™ cobalt chrome alloy femoral heads and Universal Taper Biolox® Delta Ceramic heads when using a titanium alloy sleeve. Thus, Exeter® stem size range cleared in K011623 will be compatible with V40™ Taper femoral heads manufactured frome alloy, alumina ceramic, Biolox® delta ceramic (Zirconia toughened), and stainless steel and a Universal Taper femoral heads manufactured from Biolox® delta ceramic only when using a titanium alloy adaptor sleeve.
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only .
The Exeter® Hip 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
JDI, HDI
Device Description
The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Testing has been performed to demonstrate equivalence of the subject device intended use compared to its predicate device intended use. Additional testing was conducted on the cobalt chrome alloy and Universal taper Biolox® delta ceramic femoral heads with the corresponding titanium alloy sleeves when used with Exeter® stainless steel femoral stems.
New testing to support this additional compatibility for the Exeter® Femoral Stem with cobalt chrome femoral heads includes an Axial Pull-off testing.
New testing to support this additional compatibility for the Exeter® Femoral Stem with the Universal taper Biolox® delta ceramic femoral heads with titanium sleeve includes Axial fatigue & post fatigue ultimate compression testing (according to ISO 7206-10), Axial pull-off testing (according to ISO 7206-10) and ultimate compression testing on both new and "damaged or used" femoral stem tapers (per ISO 7206-6).
For both the cobalt chrome alloy heads and titanium alloy sleeves when used with stainless steel Exeter Stems, testing for galvanic corrosion (according to ASTM G 71-81) was conducted and fretting was evaluated as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K972228, K993601, K022077, K061434, K010757, K070885
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
SEP 2 7 2011
| Sponsor | Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Valerie Giambanco
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201)-831-6275
Fax: (201)-831-3275 |
| Proprietary Name: | Exeter® Hip Stem |
| Common Name: | Artificial Hip Replacement Components - Femoral Stem |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer semi-constrained
cemented prosthesis |
| Regulatory Class: | Class II |
| Product Codes: | JDI |
| Predicate Device: | Exeter V40 Hip System |
| Date Prepared: | September 20, 2011 |
510(k) Summary of Safety and Effectiveness
Description:
The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.
Intended Use:
The Exeter® hip is intended for use in total hip arthroplasty. They are intended for cemented use only. The Exeter® hip is provided sterile for single-use.
The Exeter® Femoral Stems are currently cleared for use with femoral heads manufactured from Zirconia, alumina ceramic, Biolox® delta ceramic, and stainless steel. The purpose of this 510(k) is that the Exeter® stems will now be marketed as compatible with Howmedica Osteonics' V40™ cobalt chrome alloy femoral heads and Universal Taper Biolox® Delta Ceramic heads when using a titanium alloy sleeve. Thus, Exeter® stem size range cleared in K011623 will be compatible with V40™ Taper femoral heads manufactured frome alloy, alumina ceramic, Biolox® delta ceramic (Zirconia toughened), and stainless steel and a Universal Taper femoral heads manufactured from Biolox® delta ceramic only when using a titanium alloy adaptor sleeve.
Indications:
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only .
The Exeter® Hip is indicated for:
lot 2.
1
- 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.
Substantial Equivalence:
The Exeter® hip stem continues to be manufactured from the same material via the same process and same design as the Exeter® hips that were cleared in K011623. The Exeter® Hip Stems are substantially equivalent to other commercially available hip arthroplasty systems in regards to indications for use design, materials, and operational principles. The femoral head compatibility of the Exeter Hip Stem is substantially equivalent to Meridian TMZF Femoral Hip Stem that was cleared via K972228 . The following devices are examples of predicate systems currently cleared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V40™ taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885).
Summary of Technologies: The technological characteristics (material, design, sizes, and operational principles) of the Exeter® V40™ Hip Stem are similar or identical to the predicate devices.
Summary of Non-Clinical Testing and Evaluation:
Testing has been performed to demonstrate equivalence of the subject device intended use compared to its predicate device intended use. Additional testing was conducted on the cobalt chrome alloy and Universal taper Biolox® delta ceramic femoral heads with the corresponding titanium alloy sleeves when used with Exeter® stainless steel femoral stems.
New testing to support this additional compatibility for the Exeter® Femoral Stem with cobalt chrome femoral heads includes an Axial Pull-off testing.
New testing to support this additional compatibility for the Exeter® Femoral Stem with the Universal taper Biolox® delta ceramic femoral heads with titanium sleeve includes Axial fatigue & post fatigue ultimate compression testing (according to ISO 7206-10), Axial pull-off testing (according to ISO 7206-10) and ultimate compression testing on both new and "damaged or used" femoral stem tapers (per ISO 7206-6).
For both the cobalt chrome alloy heads and titanium alloy sleeves when used with stainless steel Exeter Stems, testing for galvanic corrosion (according to ASTM G 71-81) was conducted and fretting was evaluated as compared to the predicate device.
Clinical Testing
None provided as a basis for substantial equivalence
Conclusion
The Exeter® V40™ Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification
p. 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines forming its body and wings, suggesting movement or flight. The bird is enclosed within a circle, and there are some characters around the circle, but they are too small to read.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W 066-G609 Silver Spring, MD 20093-0002
Howmedica Osteonies Corp. % Ms. Valerie Giambanco 325 Corporate Drive Regulatory Affairs Specialist Mahwah, New Jersey 07430
SEP 2 7 2011
Re: K110290
Trade/Device Name: The Exeter® V40 hip stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: HDI Dated: August 16, 2011 Received: August 17, 2011
Dear Ms. Giambanco:
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 is 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Valerie Giambanco
forth in the quality svstems (QS) regulation (2) 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.html 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/Safetv/ReportalProblem/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.
Ernst Keith
C, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K110290
Indications for Use:
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip 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.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Michael lulus for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110290