(91 days)
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No
The document describes a physical medical device (femoral head) and its intended use in hip replacement surgery. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is a component of a total hip arthroplasty, which is a surgical procedure to repair or replace a hip joint. This procedure is performed to restore function and alleviate pain in damaged hips, fitting the definition of a therapeutic intervention.
No
The text describes a Zirconia femoral head component used in total hip arthroplasty, which is a treatment device, not a diagnostic one. It replaces a damaged body part rather than identifying a medical condition.
No
The device description clearly states it is a physical component (zirconia ceramic femoral heads) used in hip arthroplasty, not software.
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.
- Device Description and Intended Use: The provided text clearly describes a Zirconia femoral head component, which is an implantable device used in total hip arthroplasty (hip replacement surgery). Its purpose is to replace a damaged part of the hip joint.
- No mention of testing samples: The description and intended use do not involve analyzing any samples from the body for diagnostic purposes.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zirconia femoral head components are to be used with other total hip components as part of a total hip arthroplasty. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. These head devices may be used with stems that are available with cementless or cement fixation.
Product codes
LZO
Device Description
These zirconia ceramic femoral heads are compatible with the new 12/14 taper interface of the Revision Hip and Tapered Hip Systems and the Spectron and Cobra stems. They are available with neck lengths of +0 to +8, and with outer diameters of 22 - 28 mm. The femoral heads are manufactured from Yttria stabilized tetragonal Zirconia (YTZP).
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 (Femoral)
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Summary of Safety and Effectiveness 1 + 14/1 Zirconia Ceramic Femoral Heads
JUL 16 133
DEVICE DESCRIPTION:
These zirconia ceramic femoral heads are compatible with the new 12/14 taper interface of the Revision Hip and Tapered Hip Systems and the Spectron and Cobra stems. They are available with neck lengths of +0 to +8, and with outer diameters of 22 - 28 mm. The femoral heads are manufactured from Yttria stabilized tetragonal Zirconia (YTZP).
INTENDED USE:
The Zirconia femoral head components are to be used with other total hip components as part of a total hip arthroplasty. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nominion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. These head devices may be used with stems that are available with cementless or cement fixation.
Contact Person and Address:
JoAnn Kuhne Manager, Regulatory and Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116
Telephone number (901) 396-2121
1
Image /page/1/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 an eagle or other bird with its wings spread, rendered in black and white. The bird's head is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. JoAnn Kuhne Manager, Regulatory and Clinical Affairs Smith and Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
JUL 1 6 1997
Re: K971414 Zirconia Ceramic 12/14 Global Taper (GT) Femoral Heads Regulatory Class: II Product Code: LZO Dated: April 15, 1997 Received: April 16, 1997
Dear Ms. Kuhne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zirconia Ceramic 12/14 Global Taper (GT) Femoral Heads are to be used only with cobaltchrome and Ti6Al4V alloy hip stems with the 5°43' Morse taper trunnions.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Ms. JoAnn Kuhne
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Ms. JoAnn Kuhne
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit 2
Indications for Use:
INTENDED USE:
The Zirconia femoral head components are to be used with other total hip components as part of a total hip arthroplasty. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. These head devices may be used with stems that are available with cementless or cement fixation. These heads have not been submitted to the FDA for identical or different intended uses.
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K971414