(26 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 Femoral Heads & Liners are designed for single use only and may be used as part of cemented total hip arthroplasty.
The Total Hip Femoral Heads are zirconium alloy or alumina ceramic devices designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. These heads are to be used with the appropriate sized crosslinked polyethylene Total Hip Liners. Total Hip Liners are to be used with corresponding titanium acetabular shells.
This document describes the Summary of Safety and Effectiveness for Total Hip Femoral Heads & Liners (K022958).
Based on the provided text, the device is a Class II medical device that is asserting substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria in a clinical study. The document explicitly states:
"A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure."
Therefore, the information regarding acceptance criteria and a detailed study proving the device meets those criteria for clinical performance (as would be typical for an AI/ML device) is not available in this document. The provided text focuses on regulatory substantial equivalence based on material, design, mechanical, and wear test data, rather than a clinical effectiveness study.
Here's a breakdown of why many of your requested points cannot be answered from the provided text:
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Acceptance Criteria & Reported Performance Table: Not applicable. The document does not define specific clinical acceptance criteria or report clinical performance metrics for the device against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through mechanical and wear testing.
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Sample Size (Test Set) & Data Provenance: Not applicable. The device's safety and effectiveness are established through reference to existing predicate devices and in vitro mechanical/wear testing, not a clinical test set.
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Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth, in the context of clinical performance evaluation, is not established or discussed.
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Adjudication Method: Not applicable.
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MRMC Comparative Effectiveness Study: Not applicable. This type of study relates to human reader performance with and without AI assistance, which is not relevant to this orthopedic implant's regulatory submission.
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Standalone Performance: Not applicable as this is a physical medical device, not an algorithm/AI.
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Type of Ground Truth Used: Not applicable in the context of clinical performance evaluation. The "ground truth" for this submission is related to the established performance of predicate devices and the results of in-vitro mechanical and wear tests.
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Sample Size (Training Set): Not applicable. There is no "training set" for this type of device.
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How Ground Truth for Training Set was Established: Not applicable.
Summary of Device Equivalence (from the text):
The regulatory submission for the Total Hip Femoral Heads & Liners (K022958) establishes substantial equivalence to existing predicate devices based on:
- Intended Use: Similar to currently marketed femoral heads and liners.
- Material: Similar to currently marketed femoral heads and liners (zirconium alloy or alumina ceramic for heads, crosslinked polyethylene for liners).
- Design Features: Similar to currently marketed femoral heads and liners.
- Mechanical and Wear Test Data: "A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure."
Predicate Devices for Substantial Equivalence:
- Total Hip Femoral Heads:
- Total Hip Liners:
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OCT 02 2002
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Smith & Nephew, Inc. Summary of Safety and Effectiveness :Total Hip Femoral Heads & Liners
Contact Person and Address
Date of Summary: September 5, 2002
Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedics Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566 Name of Device: Total Hip Femoral Heads & Liners Common Name: Femoral heads and acetabular liners
Device Classification Name
21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis:Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis: Class II
21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis: Class II
Substantial Equivalence Information
The Total Hip Femoral Heads are substantially equivalent to Sulzer Inter-Op CoCr heads (K993259). Osteonics Alumina C-Taper Heads (K003391), and currently marketed heads distributed by Smith & Nephew. The Total Hip Liners are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Inserts (K993259 & K002575), DePuy Duraloc Acetabular Cup System (K010171), and Smith & Nephew crosslinked polyethyelene liners.
Device Description
The Total Hip Femoral Heads are zirconium alloy or alumina ceramic devices designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. These heads are to be used with the appropriate sized crosslinked polyethylene Total Hip Liners. Total Hip Liners are to be used with corresponding titanium acetabular shells.
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 Femoral Heads & Liners are designed for single use only and may be used as part of cemented total hip arthroplasty.
Technological & Performance Characteristics:
The Total Hip Femoral Heads and Liners are similar to currently marketed femoral heads and liners. These components share the same intended use, material, and design features of one or more of the above mentioned predicates. A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they also resemble a bird in flight. The profiles are depicted in black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kim P. Kelly Project Manager, Regulatory & Clinical Affairs Smith and Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
OCT 02 2002
Re: K022958
Trade/Device Name: Total Hip Femoral Heads and Liners Regulation Number: 21 CFR 888.3350, 888.3353, 888.3358
Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis;
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class: Class II Product Code: JDI, LZO, LPH Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. 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 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.
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Page 2 -- Mr. Kim P. 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 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" (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,
R. Martin A. McMillan
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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K077958
Page 1 of
Total Hip Femoral Heads & Liners - 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
Prescription Use
OR
(Per 21 CFR 801.109)
Over-The Counter Use
A. Mula A. Milliman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022958
§ 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.