(29 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) with variations in size and offset. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device is intended for treating hip pain and restoring hip motion in patients undergoing total hip arthroplasty, which are considered therapeutic actions.
No
The device, a lateralized stem for hip arthroplasty, is an implantable medical device used for treatment (relieving pain and restoring motion), not for diagnosing conditions.
No
The device description clearly states it is a "Lateralized Stem," which is a physical implant used in hip arthroplasty. It describes physical characteristics like size, offset, and CCD angle, and mentions material and surface characteristics. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating patients undergoing total hip arthroplasty due to disease or trauma to the femoral head and neck. This is a surgical procedure, not a diagnostic test performed on samples from the body.
- Device Description: The device is a surgical implant (a lateralized stem for a hip replacement).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. 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)
JDI, LWJ
Device Description
We added 12 sizes, sizes 1 through 12, of lateralized stems to the SLDevice PLUS® Stems, which were cleared for marketing by FDA on 7/25/00 Modification (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 CCD angle is 123° compared to 131° for the standard SL-PLUS® Stem. Material and surface characteristics remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral component
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)
Biomechanical fatigue tests have been performed on the worst-case model. The test results were equal or better to the predicate and other commercially available devices, and they are sufficient for in vivo loading.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
AY 1 4 ZUUZ
SPECIAL 510(K) DEVICE MODIFICATION SL-PLUS® Lateralized Stem April 15, 2002
Kou178
page 1 of 1
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact:
PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: 858-550-3800 x 2506 Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs
SL-PLUS® Lateralized Stem Trade name:
Total Hip Joint, Femoral Component, Cementless Common name:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Classification 21 CFR 888.3350 (87 LWJ and 87 JDI) name:
SL-PLUS® and SLR-PLUS® Stems, K001942, S/E 7/25/00 Equivalence:
We added 12 sizes, sizes 1 through 12, of lateralized stems to the SL-Device Modification PLUS® Stems, which were cleared for marketing by FDA on 7/25/00 Description: (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 CCD angle is 123° compared to 131° for the standard SL-PLUS® Stem. Material and surface characteristics remain unchanged.
Indications:
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
Biomechanical fatigue tests have been performed on the worst-case model. Performance data: The test results were equal or better to the predicate and other commercially available devices, and they are sufficient for in vivo loading.
15
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2002
Mr. Hartmut Loch, RAC Director, Regulatory Affairs Plus Orthopedics 6055 Lusk Blvd. San Diego, CA 92121-2700
Re: K021178
Trade/Device Name: SL-Plus® Lateralized Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LWJ Dated: April 15, 2002 Received: April 15, 2002
Dear Mr. Loch:
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 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 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.
2
Page 2 - Mr. Hartmut Loch, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
O Mark N Milbersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SPECIAL 510(K) DEVICE MODIFICATION SL-PLUS® Lateralized Stem April 15, 2002
Page 1
510(k) Number: O21178
Device Name(s):
SL-PLUS® Lateralized Stem
Indications for Use:
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Mulkern
Division of General. Restorative and Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
(Optional format 1-2-96)
Over-The-Counter-Use No