(119 days)
Not Found
No
The document describes a mechanical hip implant and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, a "Modular Proximally Fluted Hip Stem," is intended for use in hip replacement surgeries to treat various joint diseases and traumatic injuries, which are therapeutic interventions.
No
The device description clearly states it is a hip component, specifically a Modular Proximally Fluted Hip Stem, which is an implant used in surgery for damaged hips. Its intended use is for treatment and rehabilitation, not for diagnosing conditions.
No
The device description clearly states the device is a "Modular Proximally Fluted Hip Stem" manufactured from titanium alloy, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for treating hip joint issues. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a hip stem, a physical implant. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- No mention of biological samples: The text does not mention the device being used with blood, urine, tissue, or any other biological sample.
- Performance Studies: The performance studies focus on mechanical properties and fatigue, which are relevant to surgical implants, not diagnostic tests.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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 (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.
Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO
Device Description
Subject of this Abbreviated 510(k) premarket notification is the Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MDF Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is a straight, tapered, distally fixed stem with a modular female 12/14 neck taper. The subject device is manufactured from titanium alloy (Ti-6Al-4V) and has a grit-blast finish. The stems will be available in lengths of 240mm and 300mm in sizes 12-27. The subject devices will mate with the cobalt chrome modular necks cleared with the MDF Revision Hip Stems in premarket notification K081124, but are not designed to utilize the modular sleeves included as part of the MDF Revision Hip System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Performance testing has been conducted for the subject devices in accordance with the following guidance documents:
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
Environmental corrosion fatigue, post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the subject device was also evaluated. A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject 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
APR 1 9 2012
Smith & Nephew, Inc. Summary of Safety and Effectiveness Modular Proximally Fluted Hip Stem
Date of Summary: 4/12/2012
Contact Person and Address Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161
Name of Device: Smith & Nephew Modular Proximally Fluted Hip Stem Common Name: Femoral Hip Prosthesis
Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Device Class: II
Panel Code: Orthopaedics/87 MEH, LZO
Device Description
Subject of this Abbreviated 510(k) premarket notification is the Modular Proximally Fluted Hip Stem. The subject device is a line addition to the MDF Revision Hip System cleared via premarket notification K081124. The Modular Proximally Fluted Hip Stem is a straight, tapered, distally fixed stem with a modular female 12/14 neck taper. The subject device is manufactured from titanium alloy (Ti-6Al-4V) and has a grit-blast finish. The stems will be available in lengths of 240mm and 300mm in sizes 12-27. The subject devices will mate with the cobalt chrome modular necks cleared with the MDF Revision Hip Stems in premarket notification K081124, but are not designed to utilize the modular sleeves included as part of the MDF Revision Hip System.
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 (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.
Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Performance Data
Performance testing has been conducted for the subject devices in accordance with the following guidance documents:
1
-
Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
-
Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant Components, dated May 1995
Environmental corrosion fatigue, post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the subject device was also evaluated. A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew Modular Proximally Fluted Hip Stems are substantially equivalent to the MDF Revision Hip Stems cleared in premarket notification K081124. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices. A comparison of the Modular Proximally Fluted Hip Stem to the predicate device is provided in Table 1 below.
| Design Features | Device Names | |
|---|---|---|
| Subject Smith & Nephew | ||
| Modular Proximally | ||
| Fluted Hip Stem | Smith & Nephew MDF | |
| Revision Hip Stem | ||
| (K081124) | ||
| Similar Indications for | ||
| Use/Intended Use | Yes | Yes |
| Size Offering | 12-27 | 11-25 |
| Stem Lengths (mm) | 240mm; 300mm | 240mm; 300mm |
| Stem Material | Ti-6AL-4V | Ti-6AL-4V |
| Fluted Tapered Stem | Yes | Yes |
| Modular Sleeves | No | Yes |
| Neck Taper | 12/14 | 12/14 |
| Cobalt Chrome | ||
| Modular Necks | Yes | Yes |
Table 1: Comparison of the Modular Proximally Fluted Hip Stems to Predicate Device
Conclusion
This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the Modular Proximally Fluted Hip Stems. Based on the similarities to the predicate devices are substantially equivalent to femoral stem components currently marketed under K081124.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES .
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Incorporated % Ms. Natalie P. Williams Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
APR 1 9 2012
Re: K113789
Trade/Device Name: Smith & Nephew Modular Proximally Fluted Hip Stem 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, LZO Dated: April 12, 2012 Received: April 13, 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 for assossion 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). and coometre i rove, roo the the device, subject to the general controls provisions of the Act. The I ou may a 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 adulteration. Ticasonote. ODFET as tevice 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 If your device is elassified (boo are 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 I lease be devices and i 12 mination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I coolar statuted and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY an 007), lucemig (21 OFF 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Natalie P. Williams
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 A. Millherson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K1137
510(k) Number (if known):
Device Name: Smith & Nephew Modular Proximally Fluted Hip Stem
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 (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.
Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart Cl
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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