(177 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and its material properties and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
Explanation: The device is a femoral stem implanted to relieve hip pain and restore hip motion in patients with advanced hip joint wear due to various conditions, which fits the definition of a therapeutic device.
No
The device description indicates that the SL-PLUS® stems are implants made from forged titanium alloy with a coating, designed to relieve hip pain and restore hip motion. This is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical femoral stem made from titanium alloy with coatings, indicating it is a hardware device.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a femoral stem, which is an implant used in hip replacement surgery. Its intended use is to treat conditions affecting the hip joint and restore hip motion.
- Lack of Diagnostic Activity: The device itself does not perform any tests on biological samples to diagnose a condition. It is a physical implant used for treatment.
Therefore, based on the provided information, the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA are not IVDs. They are surgical implants.
N/A
Intended Use / Indications for Use
The SL-PLUS° Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SL-PLUS* Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, LWJ
Device Description
The SL-PLUS Standard and Lateral Stems with Ti/HA are based on the uncoated design of SL-PLUS® Standard and Lateral Femoral Stems cleared via K072852. The subject stems are made from forged titanium alloy Ti-6Al-4Nb with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femoral head, femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Stem Fatigue Testing
Neck Fatigue Testing
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
K120211 (pg 1/2)
JUL 1 9 2012
510(k) Summary SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 23, 2012 |
| Contact Person. | John Connor, Regulatory Affairs Specialist
T (901) 399-5944 F (901) 566-7961 |
| Name of Device: | SL-PLUS° Standard and Lateral Femoral Stem
with Ti/HA |
| Common Name: | Total Hip Joint, Femoral Component,
Cementless |
| Device Classification Name and Reference: | 21 CFR 888.3353 - Hip joint
metal/polymer/metal semi-constrained
cemented or nonporous uncemented
prosthesis
21 CFR 888.3390 - Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented
prosthesis
21 CFR 888.3360 - Hip joint femoral (hemi-hip)
metallic cemented or uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LZO, KWY, LWJ |
Device Description
The SL-PLUS Standard and Lateral Stems with Ti/HA are based on the uncoated design of SL-PLUS® Standard and Lateral Femoral Stems cleared via K072852. The subject stems are made from forged titanium alloy Ti-6Al-4Nb with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.
Intended Use
The SL-PLUS Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
1
The SL-PLUS Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Technological Characteristics
A review of the mechanical data indicates that the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The overall design, materials, and indications for use for the SL-PLUS° Standard and Lateral Femoral Stems with Ti/HA are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-----------------------------------|---------------------------------------------|----------------------|-------------------|
| Smith & Nephew
Orthopaedics AG | SL-PLUS® Standard and Lateral Femoral Stems | K072852 | 2/9/09 |
| Smith & Nephew
Orthopaedics AG | POLARCUP® Dual Mobility System | K110135 | 10/14/11 |
The following tests were used as a basis for the determination of substantial equivalence:
- Stem Fatigue Testing ●
- Neck Fatigue Testing .
All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF – 1762, Amendment 1 and are not included in this dossier.
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the SL-PLUS Standard and Lateral Femoral Stems with Ti/HA. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed above.
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 or bird symbol, with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 19 2012
Smith & Nephew, Inc. % Mr. John Connor Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, TN 38116
Re: K120211
Trade/Device Name: SL-PLUS Standard and Lateral Femoral Stem with TifHA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWY, LWJ Dated: July 12, 2012 Received: July 13, 2012
Dear Mr. Connor:
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 r ou may, are severy hims of the Act include requirements for annual registration, listing of general only is provisitive, 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 r lease be deviloed a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I edolul statutes and equirements, including, but not limited to: registration and listing (21
3
Page 2 – Mr. John Connor
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 (OS) 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,
for Nat Nolin.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
SL-PLUS Standard and Lateral Femoral Stem with Ti/HA Device Name:
Indications for Use:
The SL-PLUS° Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SL-PLUS* Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use _ (Optional Format 1-2-96)
(Please Do NoT WRITE BELOW THIS LINE – Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ASh
(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120211