(26 days)
Not Found
No
The document describes a mechanical hip implant and does not mention any AI or ML components or functionalities.
Yes
The device is a hip component intended for primary and revision hip surgery to treat damaged hips resulting from trauma or degenerative joint diseases. This falls under the definition of a therapeutic device as it is designed to treat an injury or disease.
No
This device is a hip implant component used in primary and revision surgery. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "straight, tapered, proximally loaded stem" manufactured from titanium alloy and proximally coated, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Hip Stem component," which is an implantable orthopedic device used in hip replacement surgery.
- Intended Use: The intended use describes the surgical procedures and conditions for which the hip components are indicated. This involves implantation into the body, not testing of samples outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
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 SMF° Hip Stem 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)
LPH
Device Description
The Smith & Nephew SMP Hip Stem is a straight, tapered, proximally loaded stem designed to match the geometry of the femur. The subject monoblock SMF° femoral stem line additions are offered in sizes 1 - 9. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMF® monoblock femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, 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)
Performance testing has been conducted for the subject devices in accordance with the following guidance documents:
- Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant . Components, dated May 1995
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007 .
Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or 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
§ 888.3358 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
OCT 24 2012
Smith & Nephew, Inc. ummary of Safety and Effectiveness SMF® Hip Stem Line Additions
Date of Summary: 9/27/2012
Contact Person and Address
Natalie P. Williams Senior Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161
Name of Device: Smith & Nephew SMF® Hip Stem Common Name: Hip Stem Device Classification Name and Reference: 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 LPH
Device Description
The Smith & Nephew SMP Hip Stem is a straight, tapered, proximally loaded stem designed to match the geometry of the femur. The subject monoblock SMF° femoral stem line additions are offered in sizes 1 - 9. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMF® monoblock femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.
Intended 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 SMP Hip Stem 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
- Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant . Components, dated May 1995
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007 .
Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Substantial Equivalence Information
The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew SMF° Hip Stem line additions are substantially equivalent to the SMP Hip Stems cleared in premarket notification K103256. 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.
| Feature | Subject SMF® Hip Stem
Line Additions | Predicate SMF® Hip Stems
(K103256) |
|--------------------------------------------------|-----------------------------------------|---------------------------------------|
| Similar Indications
for Use | ✓ | ✓ |
| Size Offering | 1 - 9 | -1 and 0 |
| Stem Material | Ti-6Al-4V | Ti-6Al-4V |
| Tapered Stem
Geometry | ✓ | ✓ |
| Medial Grit-Blasted
Surface Finish | ✓ | ✓ |
| Proximal Porous
Coating | ✓ | ✓ |
| Glass Bead Distal Tip | ✓ | ✓ |
| Fixed Neck | ✓ | ✓ |
| Neck Taper | 12/14 | 12/14 |
| Standard and High
Offset Options
Available | ✓ | ✓ |
| Polished Neck Area | ✓ | ✓ |
Table 1: Comparison of Size -1 and 0 Femoral Stems to Predicate Device
Conclusion
This Special 510(k) Premarket Notification is being submitted to request clearance for the sizes 1 - 9 SMF Hip Stem line addition components. Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to the femoral stem components currently marketed under K103256.
2
Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 24 2012
Smith & Nephew, Inc. % Ms. Natalie P. Williams Senior Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, TN 38116
Re: K123012
Trade/Device Name: Smith & Nephew SMF 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 27, 2012
Received: September 28, 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 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,
fee Duth lind.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K1230126pg1117
510(k) Number (if known): K123012
Device Name: Smith & Nephew SMF 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 SMF° Hip Stem components are intended for single use only and are to be implanted without bone cement.
Prescription Use × (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)
AND/OR
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1
| Labels | Values |
|---|---|
| 510(k) Number | K123012 |