(75 days)
K896580, K02374-3
No
The document describes a mechanical orthopedic implant (femoral heads) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a modular femoral head designed for hemi-hip replacement, which is a surgical procedure to treat various joint diseases and traumatic injuries, directly addressing and alleviating medical conditions.
No.
The device is a modular femoral head used as part of a hemi-hip replacement system, which is a treatment for various joint diseases and fractures, not a tool for diagnosis.
No
The device description clearly states the device is a physical, cobalt chrome modular femoral head, which is a hardware component for hip replacement surgery.
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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided text describes a modular femoral head, which is a component of a hip replacement system. This is an implantable device used within the body to replace a damaged part of the hip joint.
- Intended Use: The intended use clearly states that the device is for surgical procedures to treat various conditions affecting the hip joint. This is a therapeutic intervention, not a diagnostic test.
The description of the device, its intended use, and the anatomical site all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- . rheumatoid arthritis;
- arthritis secondary to a variety of diseases :: nd anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other freatments: have failed; and .
- treatment of proximal femoral non-union, fe moral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
Product codes
KWL
Device Description
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offiered in sizes ranging from 38-58mm and feature a 12/14 taper interface to allow the components to be used in conjunction with existing Smith & Nephew femoral components. The overall designs of the components are based upon existing Uni-polar implants subject of K896580.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hemi-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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K896580, K02374-3
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K061243 page if
510(K) Summary
Smith & Nephew Modular Femoral Heads
JUL 17 2006
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | May 2, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Modular Femoral Heads |
| COMMON OR USUAL NAME: | Artificial Hip Replacement Prosthesis |
| CLASSIFICATION NAME: | Hip joint femoral (hemi-hip) metallic cemented or uncemented |
| prosthesis, 21 CFR 888.3360 | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | KWL - prosthesis, hip, hemi-, femoral, metal |
| Orthopedics Panel/87 |
A. INTENDED USE:
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- . rheumatoid arthritis;
- arthritis secondary to a variety of diseases :: nd anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other freatments: have failed; and .
- treatment of proximal femoral non-union, fe moral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
DEVICE DESCRIPTION: B.
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offiered in sizes ranging from 38-58mm and feature a 12/14 taper interface to allow the components to be used in conjunction with existing Smith & Nephew femoral components. The overall designs of the components are based upon existing Uni-polar implants subject of K896580.
SUBSTANTIAL EQUIVALENCE INFORMATION: ﺰ
The Smith & Nephew Modular Femoral Heads are :: imilar to the following commercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew Uni-Polar Head (K896580)
- · Smith & Nephew Global Bipolar System (K02374-3)
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2006
Smith & Nephew, Inc. % Mr. Gino J. Rouss, MS Orthopaedics Division Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K061243
.
Trade/Device Name: Smith & Nephew Modular Femoral Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: May 1, 2006 Received: May 3, 2006
Dear Mr. Rouss:
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.
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
2
Page 2 - Mr. Gino J. Rouss, MS
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" (21 CFR 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 vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K061443
Device Name: Smith & Nephew Modular Femorial Heads
Indications for Use:
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disea:se including osteoarthritis, osteonecrosis, . avascular necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- medifiatold arthinis,
arthritis secondary to a variety of diseases and anomalies and correction of functional . deformity such as congenital hip dysplasia or ankylosing spondylitis; - revision procedures where other treatments have failed; and .
- revision procedures when of who an on-union, femoral neck fracture, and trochanteric . fractures of the proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemihip replacement system when articulating agains: the natural acetabulum.
AND/OR ` Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchum
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of General, Restorative, and Neurological Devices
510(k) Number_ Kolo/242