(27 days)
No
The document describes a hip implant and its material properties and design modifications, with no mention of AI or ML technology.
Yes
Explanation: The device, ANTHOLOGY AFIT Hip Stem, is indicated for individuals undergoing primary and revision surgery to rehabilitate hips damaged by trauma or degenerative joint diseases. It is explicitly designed to treat a medical condition and restore function, aligning with the definition of a therapeutic device.
No
This document describes a hip stem, which is an implantable medical device used in hip replacement surgery to treat damaged hips. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the device is a hip stem manufactured from Titanium alloy and describes its physical characteristics and coatings. This indicates a physical implant, not a software-only device.
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 replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a hip stem made of titanium alloy, designed for surgical implantation. This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies mentioned focus on pyrogen testing (related to sterility and safety for implantation), not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
N/A
Intended Use / Indications for Use
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 or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
The ANTHOLOGY AFIT Hip Stem is for single use only. The ANTHOLOGY AFIT Hip Stem is intended for cementless use.
Product codes
LPH
Device Description
Subject of this Special premarket notification is the addition of a new stem design to the Smith & Nephew ANTHOLOGY™ Hip System. The ANTHOLOGY Hip System currently consists of the ANTHOLOGY Hip Stems cleared via premarket notification K052792. The proposed devices are ANTHOLOGY™ AFIT Hip Stems, new hip stems that will be marketed as part of the ANTHOLOGY Hip System.
The ANTHOLOGY AFIT Hip Stem represents minor design modifications when compared to the predicate ANTHOLOGY Hip Stem cleared via K052792. The ANTHOLOGY AFIT Hip Stem is manufactured from Titanium alloy (Ti-6Al-4V) per ASTM F1472. The proximal body is both porous-coated per ASTM F67 and hydroxyapatite-coated, the middle section is grit-blasted, and the distal end is glassbeaded. The ANTHOLOGY AFIT Hip Stem will be available in a size range of 3 to 14, in both a high and standard neck offset with a 12/14 taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femur
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)
A review of the existing ANTHOLOGY Hip Stem testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
"The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of less than or equal to 20 EU/device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Public Health Service
October 3, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Jonathan DiMotta Regulatory Affairs Specialist I 1450 East Brooks Road Memphis. Tennessee 38116
Re: K172684
Trade/Device Name: Smith & Nephew Inc. ANTHOLOGY-104 AFIT Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: September 5, 2017 Received: September 6, 2017
Dear Mr. DiMotta:
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 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K172684
Device Name
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
Indications for Use (Describe)
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 or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
The ANTHOLOGY AFIT Hip Stem is for single use only. The ANTHOLOGY AFIT Hip Stem is intended for cementless use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 2, 2017 |
| Contact Person and Address: | Jonathan DiMotta
Regulatory Affairs Specialist I
T 901-399-5471
F 901-566-7535 |
| Name of Device: | Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem |
| Common Name: | Hip Stem |
| Device Classification Name and
Reference: | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LPH |
Device Description
Subject of this Special premarket notification is the addition of a new stem design to the Smith & Nephew ANTHOLOGY™ Hip System. The ANTHOLOGY Hip System currently consists of the ANTHOLOGY Hip Stems cleared via premarket notification K052792. The proposed devices are ANTHOLOGY™ AFIT Hip Stems, new hip stems that will be marketed as part of the ANTHOLOGY Hip System.
The ANTHOLOGY AFIT Hip Stem represents minor design modifications when compared to the predicate ANTHOLOGY Hip Stem cleared via K052792. The ANTHOLOGY AFIT Hip Stem is manufactured from Titanium alloy (Ti-6Al-4V) per ASTM F1472. The proximal body is both porous-coated per ASTM F67 and hydroxyapatite-coated, the middle section is grit-blasted, and the distal end is glassbeaded. The ANTHOLOGY AFIT Hip Stem will be available in a size range of 3 to 14, in both a high and standard neck offset with a 12/14 taper.
Intended Use
Hip components are indicated for individuals underqoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
4
The ANTHOLOGY AFIT Hip Stem is for single use only. The ANTHOLOGY AFJT Hip Stem is intended for cementless use.
Technological Characteristics
A review of the existing ANTHOLOGY Hip Stem testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
"The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of less than or equal to 20 EU/device."
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, material composition, and very similar in overall design to the ANTHOLOGY Hip Stem cleared via premarket notification K052792.
Table 1: Substantially Equivalent Predicate to the ANTHOLOGY AFIT Hip Stem
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|--------------------|----------------------|-----------------|
| Smith & Nephew, Inc. | ANTHOLOGY Hip Stem | K052792 | October 7, 2005 |
Conclusion
This Special 510(k) premarket notification is being submitted to request clearance for the ANTHOLOGY AFIT Hip Stem. Based on the similarities to the predicate device and a review of the existing mechanical testing performed, the subject devices are substantially equivalent to the predicate ANTHOLOGY Hip Stem.