(249 days)
No
The document describes a hip stem implant and does not mention any AI or ML components or functionalities.
Yes
The device is intended to relieve hip pain and restore hip motion, which are therapeutic effects for patients suffering from hip joint conditions.
No
Explanation: This device, the SL-PLUS Stem, is an orthopedic implant for hip replacement. Its purpose is to relieve pain and restore motion, not to diagnose a condition.
No
The device description clearly states it is a physical hip stem made of titanium alloy, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip stem intended for surgical implantation to relieve hip pain and restore hip motion due to various conditions affecting the hip joint and femoral head. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics, material, and design of a hip implant. It does not describe any components or processes related to testing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status or disease
- Using reagents or assays
- Performing tests in a laboratory setting
The device described is a surgical implant used to treat a condition, which falls under the category of a medical device, but specifically a therapeutic one, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SL-PLUS Stem 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 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
Subject of this premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively.
Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-6Al-7Nb titanium alloy according to ASTM F1295-05 and ISO 5832-11. The primary stem SL-PLUS is available in 14 size options.
The SL-PLUS lateralized version is an additional 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS Stem, thus giving the surgeon a further option to meet the patient's anatomy. The Caput Collum Diaphysis (CCD) angle is 123° compared to 131° for the standard SL-PLUS Stem. The material and surface characteristics remain unchanged for the lateralized stem as compared to the standard stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, proximal femur
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)
Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
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.
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.
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510(K) Summary Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem
| JUN - 9 2008 | |||
|---|---|---|---|
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division | ||
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 | ||
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6017 | ||
| CONTACT PERSON: | Nicholas B. Tabrizi | ||
| DATE SUMMARY PREPARED: | September 6, 2007 | ||
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem | ||
| COMMON OR USUAL NAME: | Total Hip Joint, Femoral Component, Cementless | ||
| CLASSIFICATION NAME: | 21 CFR | ||
| 888.3353, | |||
| LZO | Hip joint metal/ceramic/polymer semi- | ||
| constrained cemented or nonporous | |||
| uncemented prosthesis. | |||
| 21 CFR | |||
| 888.3390, | |||
| KWY | Hip joint femoral (hemi-hip) metal/polymer | ||
| cemented or uncemented prosthesis. | |||
| 21 CFR | |||
| 888.3360, | |||
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or | ||
| uncemented prosthesis. | |||
| DEVICE CLASS: | Class II | ||
| PANEL CODE: | Orthopaedics/87/LWJ, LZO, KWY | ||
A. INTENDED USE:
The SL-PLUS Stem 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 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.
B. DEVICE DESCRIPTION:
Subject of this premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively.
Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-6Al-7Nb titanium alloy according to ASTM F1295-05 and ISO 5832-11. The primary stem SL-PLUS is available in 14 size options.
The SL-PLUS lateralized version is an additional 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS Stem, thus giving the surgeon a further option to meet the patient's anatomy. The Caput Collum Diaphysis (CCD) angle is 123° compared to 131° for the standard SL-PLUS Stem. The material and surface characteristics remain unchanged for the lateralized stem as compared to the standard stem.
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ட். SUBSTANTIAL EQUIVALENCE INFORMATION:
The overall designs and the indications for use for the Smith & Nephew SL PLUS Standard and Lateral Femoral Stem are substantially equivalent to the PLUS Orthopedics SL-Plus and SL-Plus Lateralized Stems cleared for market under 510(k) Notifications K001942 and K021178, respectively.
The Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are similar to the following commercially available devices regarding design features, overall indications, and materials:
| Manufacturer | Description | 510(K) | Clearance Date |
|---|---|---|---|
| Encore Orthopedics, | |||
| Inc. | SL-PLUS AND SLR-PLUS | K932481 | 06/08/94 |
| PLUS Orthopedics. | SL-PLUS AND SLR-PLUS | K001942 | 07/25/00 |
| PLUS Orthopedics | SL-PLUS Lateralized | K021178 | 05/14/02 |
D. SUMMARY OF TECHNOLOGICAL COMPARISON:
The intended use, design, and materials of the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are substantially equivalent to the previously cleared PLUS Orthopedics SL-Plus and SLR-Plus, and the SL-PLUS Lateralized Stems (K001942 & K021178). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, bold design, and the text is in a clear, sans-serif font. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Smith & Nephew, Inc. Orthopaedic Division c/o Mr. Nicholas B. Tabrizi Regulatory Affairs Specialist II 1450 East Brooks Road Memphis, Tennessee 38116
Re: K072852
Trade/Device Name: Smith & Nephew SL-PLUS Standard and Lateral Femoral Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented Regulatory Class: Class II Product Code: LZO, KWY, LWY, LWJ Dated: May 30, 2008 Received: June 3, 2008
Dear Mr. Tabrizi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eederal 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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milkman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072852
Device Name: SL-PLUS Standard and Lateral Hip Stems
Indications for Use:
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SL-PLUS Lateralized Stem 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 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)
Mark A. Wilkerson
Division of General, Restorative, and Neurological Devices
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Indications.doc
510(k) Number K072852