(101 days)
Total hip components are indicated for uncemented use in 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 osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
The Smith & Nephew MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The MDF hip stem is a straight, tapered, distally fixed, modular stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 11 through 25 and have modular neck and sleeve options to address patient anatomy. The stems and sleeves are manufactured from titanium alloy (Ti-6Al-AV) and the necks are manufactured from cobalt chrome. Each modular sleeve is coated with Smith & Nephew's Stiktite porous coating. A hydroxylapatite (HA) coating will be applied to the porous coated areas of the MDF modular sleeve by a plasma spray technique.
This is a 510(k) premarket notification for a medical device (MDF Revision Hip System). The provided documents are an FDA clearance letter and the manufacturer's summary of safety and effectiveness, which primarily focuses on establishing substantial equivalence to existing predicate devices.
Consequently, the documents do not contain information related to acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC or standalone) as typically found in clinical trial reports or performance validation studies for AI/software devices.
The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed device (predicate device) and does not generally require new clinical studies to prove performance against pre-defined acceptance criteria in the same way an AI/software device would. Instead, it relies on design, material, and functional equivalence to a known safe and effective predicate.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies because the provided text does not contain this information. The document focuses on regulatory clearance through substantial equivalence.
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KOB1124 (pg 111)
Smith & Nephew, Inc. Summary of Safety and Effectiveness MDF Revision Hip System
JUL 3 1 2008
Date of Summary: 07/08/2008
Contact Person and Address Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054
Name of Device: Smith & Nephew MDF Revision Hip System Common Name: Hip Stem
Device Description
The Smith & Nephew MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The MDF hip stem is a straight, tapered, distally fixed, modular stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 11 through 25 and have modular neck and sleeve options to address patient anatomy. The stems and sleeves are manufactured from titanium alloy (Ti-6Al-AV) and the necks are manufactured from cobalt chrome. Each modular sleeve is coated with Smith & Nephew's Stiktite porous coating. A hydroxylapatite (HA) coating will be applied to the porous coated areas of the MDF modular sleeve by a plasma spray technique.
Device Classification
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis - Class II
Product Code
MEH - Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate
Indications for Use
Total hip components are indicated for uncemented use in 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 theumatoid 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 osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Substantial Equivalence Information
The overall design of the Smith & Nephew MDF Revision Hip System is substantially equivalent to previously cleared devices listed below.
| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|---|
| Smith & Nephew, Inc. | Emperion (Modular) Hip Stem | K042127 | 11/19/2004 |
| Smith & Nephew, Inc. | MIS Hip Stem | K072417 | 1/10/2008 |
| Smith & Nephew, Inc. | Anthology Hip Stem | K052792 | 10/07/2005 |
| Smith & Nephew, Inc. | Echelon Hip Stem | K963486 | 11/27/1996 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Orthopaedic Reconstruction % Mr. Rishi Sinha Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116
JUL 3 1 2008
K081124 Trade/Device Name: MDF Revision Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained Cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: MEH Dated: July 8, 2008 Received: July 15, 2008
Dear Mr. Sinha:
Re:
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. Rishi Sinha
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOBI (24 (pg 1/1)
Device Name: MDF Revision Hip System
Indications for Use:
Total hip components are indicated for uncemented use in 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 (NIDJ) or any of its composite diagnoses such as osfeoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitits with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Hip System components are intended for single use only and are to be implanted without bone cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Mark N. Melkerson
(Division Sign-Division of General, Restorative, and Neurological Devices
Page 1 of __ 1
510(k) Number K081124
§ 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.