(379 days)
No
The document describes a hip implant system and focuses on the material coating and manufacturing process. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a total hip component, which, according to the "Intended Use / Indications for Use" section, is indicated for individuals undergoing primary and revision surgery to rehabilitate hips damaged by trauma, inflammatory joint disease, or noninflammatory degenerative joint disease. Such devices are designed to treat medical conditions, thus classifying them as therapeutic devices.
No
The device description clearly states that these are "Total hip components" indicated for primary and revision surgery to replace damaged hips. These components are implants for treatment, not tools for diagnosis.
No
The device description clearly states that the device is a hip system composed of physical components (stems and shells) with a calcium phosphate coating. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as hip components (stems and shells) with a coating, intended for implantation. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on the characteristics of the coating and the implant itself, not on diagnostic accuracy or performance.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted in vivo (inside the body) for treatment.
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 traumatory 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; 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 Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.
Product codes
MEH, LPH, LWJ, and LZO
Device Description
This 510/k) submission seeks FDA clearance to have the calcium phosphate coating (plasma sprayed from hydroxyapatite (HA) powder) on the subject hip components applied by an alternate coating supplier. The calcium phosphate coating is referred to as "HA coating." The hip system components included in this premarket notification are:
- . Porous Synergy Hip Stems
- . Non-Porous Synergy Stems
- Porous Anthology Hip Stems .
- . Porous Reflection Acetabular Shells
The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K002996 and K970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K990666 and K022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not change as a result of the implementation of an alternate HA coating supplier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary reports which describe how the applicable guidance documents were used during device development and testing to address risks associated with the subject devices have been reviewed. The subject HA coating underwent characterization per the "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants." All characterization parameters on the starting powders and final coating were provided. In addition, the NIST SRM 2910|a) material was used as a comparator for X-ray diffraction, dissolution rate and solubility product parameters. Prior to being HA coated, the sintered, metallic beaded porous coatings were characterized per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The dual coatings of calcium phosphate coating on the metallic, sintered beaded coatings underwent additional characterization to demonstrate that the definition of porosity was met per 21 CFR 888.3358.
All of the observed results indicate that the Smith & Nephew Hip Systems with HA are substantially equivalent to devices currently cleared for market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052792, K002996, K970337, K990666, and K022556
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Summary of Safety and Effectiveness Smith & Nephew Hip Systems with HA
Date of Summary: April 19, 2010
Contact Person and Address:
Gino Rouss, MS Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-6707
APR 2 1 2010
| Name of Device: | Smith & Nephew Hip Systems with HA |
|---|---|
| Common Name: | Hip System |
| Device Classification: | CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis ">– Class II | |
| Device Product Codes: | MEH, LPH, LWJ, and LZO |
Device Description
This 510/k) submission seeks FDA clearance to have the calcium phosphate coating (plasma sprayed from hydroxyapatite (HA) powder) on the subject hip components applied by an alternate coating supplier. The calcium phosphate coating is referred to as "HA coating." The hip system components included in this premarket notification are:
- . Porous Synergy Hip Stems
- . Non-Porous Synergy Stems
- Porous Anthology Hip Stems .
- . Porous Reflection Acetabular Shells
The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K002996 and K970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K990666 and K022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not change as a result of the implementation of an alternate HA coating supplier.
Performance Data
Summary reports which describe how the applicable guidance documents were used during device development and testing to address risks associated with the subject devices have been reviewed. The subject HA coating underwent characterization per the "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants." All characterization parameters on the starting powders and final coating were provided. In addition, the NIST SRM 2910|a) material was used as a comparator for X-ray diffraction, dissolution rate and solubility product parameters. Prior to being HA coated, the sintered, metallic beaded porous coatings were characterized per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The dual coatings of calcium phosphate coating on the metallic, sintered beaded coatings underwent additional characterization to demonstrate that the definition of porosity was met per 21 CFR 888.3358.
All of the observed results indicate that the Smith & Nephew Hip Systems with HA are substantially equivalent to devices currently cleared for market.
1
Intended 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 traumatory 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; 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 Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.
Technological Characteristics
Although the technological characteristics of the HA coating that will be applied using a plasma spray technique may be considered the same as the predicate HA coating, performance data was provided in support of substantial equivalence. The subject 510(k) includes implant devices that contain HA coating applied to a gritblasted titanium substrate and a -45/+60 mesh size CpTi porous bead coating.
Clinical data was not needed to support the safety and effectiveness of the subject HA coated devices.
Substantial Equivalence Information
The Smith & Nephew Hip Systems with HA are similar in overall design, material and indications to the Smith & Nephew Hip Systems with HA cleared via 510(k) Premarket Notifications K052792, K002996, K970337, K990666, and K022556.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 1 2010
Smith & Nephew, Inc. % Mr. Gino Rouss, M.S. Manager, Regulatory Affairs Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K090982
Trade/Device Name: Smith & Nephew Hip Systems with HA Coating 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: MEH, LPH, LWJ, LZO Dated: April 19, 2010
Received: April 20, 2010
Dear Mr. Rouss:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 mav 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
3
Page 2 - Mr. Gino Rouss, M.S.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkers Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090982
Device Name: Smith & Nephew Hip Systems with HA
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; 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 Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.
Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)
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)
Snette
(Division Sign-Off) for mkn
Division of Surgical, Orthopedica and Restorative Devices
510(k) Number K090982