(21 days)
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 Total Hip 12/14 Taper Femoral Heads are designed for single use only.
The Total Hip 12/14 Taper Femoral Heads are designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
The provided text describes a 510(k) premarket notification for a medical device, specifically Smith & Nephew, Inc. Total Hip Femoral Heads, 12/14 taper. This document focuses on demonstrating substantial equivalence to existing devices, primarily through mechanical testing and comparison of indications for use.
Crucially, this type of submission does not involve clinical studies with human participants in the way typically required for AI/algorithm-based devices, which usually involve evaluation of diagnostic performance (e.g., sensitivity, specificity). Therefore, many of the requested elements for an AI/algorithm study (such as sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not applicable to this device and its submission.
The "study" described here is a mechanical test data review rather than a clinical study evaluating diagnostic or predictive performance.
Here's a breakdown of the information that is applicable and why other parts are not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Capable of withstanding expected in vivo loading without failure, and equivalent to devices currently on the market. | "A review of the mechanical test data indicated that the Total Hip 12/14 Taper Femoral Heads are equivalent to devices currently on the market and capable of withstanding expected in vivo loading without failure." |
| Indications for Use Equivalence: Similar indications for total hip replacement as legally marketed predicate devices (Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads). | "The Total Hip 12/14 Taper Femoral Heads are similar to the femoral heads currently distributed by Smith & Nephew, Inc. All heads are indicated for total hip replacement and are similar to Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is based on mechanical testing (simulating in vivo loading) and a comparison of product specifications and indications for use, not a clinical study involving a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for mechanical equivalence would be the established engineering standards and performance of predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Not a clinical study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/algorithmic device, nor a diagnostic device that would involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical orthopedic implant (femoral head), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" or basis for acceptance in this context is the established mechanical performance standards and regulatory requirements for hip joint prostheses, along with the demonstrated performance of legally marketed predicate devices. This is based on engineering principles and material science, not clinical outcomes data for this specific new device, as it's a 510(k) for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithmic device that uses a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithmic device that uses a "training set."
In summary: The K021673 submission for the Smith & Nephew Total Hip Femoral Heads is a premarket notification (510(k)) that demonstrates substantial equivalence to legally marketed predicate devices. The "study" referenced is a review of mechanical test data demonstrating the device's ability to withstand in vivo loading and its equivalence to market comparators, along with a comparison of its intended uses. It does not involve a clinical study with patients or an AI algorithm, and therefore most of the requested fields related to such studies are not applicable.
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K021673
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Summary of Safety and Effectiveness Smith & Nephew, Inc. Total Hip Femoral Heads, 12/14 taper
Contact Person and Address
Kim Kelly Senior Clinical and Regulatory Affairs Specialist Smith & Nephew. Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Total Hip 12/14 Taper Femoral Heads are designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
Device Classification Name
21 CFR 888.3353 Hip joint metal/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 Total Hip 12/14 Taper Femoral Heads are designed for single use only.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the Total Hip 12/14 Taper Femoral Heads are equivalent to devices currently on the market and capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The Total Hip 12/14 Taper Femoral Heads are similar to the femoral heads currently distributed by Smith & Nephew, Inc. All heads are indicated for total hip replacement and are similar to Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2002 .
Ms. Kim P. Kelly, MS Senior Regulatory & Clinical Affairs Specialist Orthopaedic Division Smith & Nephew, Inc. 1450 East Brooks Road Memphis, TN 38116
Re: K021673
Trade/Device Name: Total Hip Femoral Head - 12/14 Taper Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: May 20, 2002 Received: May 21, 2002
Dear Ms. Kelly:
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
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Page 2 - Ms. Kim Kelly
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 imarketed 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 vour 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 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,
Mark N. Milliman
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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Total Hip Femoral Heads, 12/14 taper Indications Statement
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.
Concurrence of CDRH, Office of Device Evaluation
X Prescription Use
OR (Per 21 CFR 801.109)
Over-The Counter Use -------
10f1
R. Mark N. Wilkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number .
§ 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.