(15 days)
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No
The summary describes a mechanical implant (femoral head) and its mechanical testing, with no mention of AI/ML, image processing, or data-driven algorithms.
Yes
The Zirconia Ceramic Femoral Head is indicated for use in primary and revision hip surgery to treat hips damaged due to various conditions, aiming to rehabilitate them. This direct treatment of a disease or condition to restore function classifies it as a therapeutic device.
No
Explanation: The document describes a "Zirconia Ceramic Femoral Head" which is a total hip component for surgical implantation. Its intended use is for individuals undergoing hip surgery due to various conditions, not for diagnosing those conditions. The device description and performance studies focus on its mechanical properties and suitability for implantation.
No
The device description clearly states it is a "Zirconia Ceramic Femoral Head," which is a physical implantable component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Zirconia Ceramic Femoral Head, which is a component of a total hip replacement. This is an implantable medical device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use clearly states it's for individuals undergoing hip surgery due to various conditions affecting the hip joint. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided describes a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Zirconia Ceramic Femoral Head is designed for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Zirconia Ceramic Femoral Head designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document. All of the test results indicate that the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
The Zirconia Ceramic Femoral Head with a 14/16 taper distributed by Smith & Nephew, Inc.
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.
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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
K 0/3989
ge loft
Summary of Safety and Effectiveness Smith & Nephew, Inc. Zirconia Ceramic Femoral Head
Contact Person and Address
DEC 1 9 2001
Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 396-2121
Device Description
The Zirconia Ceramic Femoral Head designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
Device Classification Name
Device Classification wetal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II
Indications for Use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Zirconia Ceramic Femoral Head is designed for single use only.
Mechanical and Clinical Data
Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document. All of the test results indicate that the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure.
Substantial Equivalence Information
The Zirconia Ceramic Femoral Head with a 12/14 taper is similar to the Zirconia Ceramic Femoral Head with a 14/16 taper distributed by Smith & Nephew, Inc. Both heads are indicated for total hip replacement and are similar in design.
CONFIDENTIAL
1
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Ms. Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116
Re: K013989
Trade/Device Name: Zirconia Ceramic Femoral Head 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 Dated: November 26, 2001 Received: December 4, 2001
Dear Ms. Green:
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 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.
2
Page 2 - Ms. Janet Johnson Green
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Zirconia Ceramic Femoral Head Indications Statement
Total hip components are indicated for individuals undergoing primary and revision Total mp Confoonchs are indicated in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses nonimalinitis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; Such as Useballunines, avascular incostrophic variant; old, remote osteomyelitis with an iused inip, fracture of the period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Signature
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K013989