(359 days)
Not Found
No
The device description and intended use focus on physical trial components for hip surgery, with no mention of AI or ML capabilities. The performance studies are limited to biocompatibility testing.
No
The device is a trial component used to determine the correct implant size, not to treat a condition itself.
No
Explanation: The device, Smith & Nephew Radiopaque Trial Necks, is used to determine the correct size of a modular neck implant during surgery, not to diagnose a medical condition. Its function is to facilitate the surgical procedure, not to identify or characterize a disease.
No
The device description clearly states the device is manufactured from polyphenylsulfone (PPSU) with barium sulfate, indicating it is a physical, hardware component used in surgery, 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 device used during surgery to determine the correct implant size for a hip replacement. This is a surgical tool, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a physical component used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on laboratory testing.
The device is a surgical trial component used for sizing during a hip replacement procedure.
N/A
Intended Use / 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 (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 osteolomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MEH
Device Description
Subject of this Traditional 510(k) are the Smith & Nephew Radiopaque Trial Necks. The Radiopaque Trial Necks are intended to be used to determine the correct modular neck implant option for the femoral stems developed as part of the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System cleared via premarket notifications K080625 and K081124, respectively.
The subject devices are manufactured from polyphenylsulfone (PPSU) with 6% of the radiopacifier barium sulfate, which makes them visible on an x-ray in the instance that they become dislodged during the trialing process. Colorants are blended with the PPSU resin to differentiate the various radiopaque trial necks. The subject devices are available in the options provided in Table 1 below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Hip, femoral
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)
Biocompatibility testing has been conducted on the subject devices according to ISO 10993:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks. Clinical data was not needed to support the safely and effectiveness of the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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5 2012
Smith & Nephew, Inc. Summary of Safety and Effectiveness Radiopaque Trial Necks
Date of Summary: 05/29/2012
Contact Person and Address
Natalie P. Williams Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161
Name of Device: Radiopaque Trial Necks Common Name: Surgical Instrumentation
Device Classification Name and Reference: 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 LPH, MEH Predicate Devices: SMF Hip Stem (K080625), MDF Revision Hip System (K081124), Promos
Reverse Shoulder System Trial Inserts (K081016)
Device Description
Subject of this Traditional 510(k) are the Smith & Nephew Radiopaque Trial Necks. The Radiopaque Trial Necks are intended to be used to determine the correct modular neck implant option for the femoral stems developed as part of the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System cleared via premarket notifications K080625 and K081124, respectively.
The subject devices are manufactured from polyphenylsulfone (PPSU) with 6% of the radiopacifier barium sulfate, which makes them visible on an x-ray in the instance that they become dislodged during the trialing process. Colorants are blended with the PPSU resin to differentiate the various radiopaque trial necks. The subject devices are available in the options provided in Table 1 below.
| Component Description | Color |
|---|---|
| Radiopaque Trial Neck Standard Offset | Natural |
| Radiopaque Trial Neck High Offset | Natural |
| Radiopaque Trial Neck Left Anteverted | Green |
| Radiopaque Trial Neck Right Anteverted | Red |
| Radiopaque Trial Neck High Offset +10MM | Natural |
| Table 1: Radiopaque Trial Neck Options | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | ---------------------------------------- | -- | -- | -- |
Intended 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 (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
1
K 113039
Page 2/2
fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Performance Data
Biocompatibility testing has been conducted on the subject devices according to ISO 10993:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks. Clinical data was not needed to support the safely and effectiveness of the devices.
Substantial Equivalence Information
The Radiopaque Trial Necks have the same indications for use as the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System. The material and sterilization of the subject devices is substantially equivalent to the Trial Inserts included in the Smith & Nephew Promos Reverse Shoulder System cleared by K081016. The design features of the Radiopaque Trial Necks have been compared to the previously cleared devices in Table 2 below.
| Feature | Subject Radiopaque
Trial Necks - K113039 | Predicate SMF
Hip Stem System
- K080625 | Predicate MDF
Revision Hip Stem
System - K081124 | Promos Reverse
Shoulder System
Trial Inserts -
K081016 |
|-----------------------------|---------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------|
| Same Indications
for Use | Yes | Yes | Yes | No |
| Implant/Instrument | Hip Trial Instruments | Hip Implants | Hip Implants | Shoulder Trial
Instruments |
| Material | Polyphenylsufone (PPSUI)
with 6% Barium Sulfate
(Color Added) | Ti-6Al-4V - Stem
Cobalt Chrome -
Modular Necks | Ti-6Al-4V - Stem and
Modular Sleeves
Cobalt Chrome -
Modular Necks | Polyphenylsufone
(Color added) |
| Sterilization | Non-sterile | Gamma
Sterilization | Gamma Sterilization | Non-sterile |
| Single Use or
Reusable | Reusable | Single Use | Single Use | Reusable |
Table 2: Comparison to Predicate Devices
Conclusion
This Traditional 510(k) premarket notification is being submitted to request clearance for the Smith & Nephew Radiopaque Trial Necks. Based on the similarities to the predicate devices and acceptable biocompatibility testing, the subject devices are considered substantially equivalent to the devices currently marketed under premarket notifications K080625, K081124, and K081016.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
. 5
2012
Smith & Nephew, Incorporated % Ms. Natalie P. Williams Sr. Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K113039
Trade/Device Name: Radiopaque Trial Necks Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; Regulatory Class: Class II Product Code: LPH, MEH Dated: October 4, 2012 Received: October 5, 2012
Dear Ms. Williams:
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. 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 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
3
Page 2 – Ms. Natalie P. Williams
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. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K113039
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Radiopaque Trial Necks
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 (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.
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (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)
ht
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of A
510(k) Number K113039