(57 days)
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No
The document describes a mechanical implant (tibial baseplate stem plugs) and its intended use in knee arthroplasty. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device, a tibial baseplate stem plug, is intended for use in patients with degenerative joint diseases and failed previous surgeries to alleviate pain, deformity, or dysfunction, which are therapeutic goals.
No
The device description indicates that the tibial baseplate stem plugs are implantable components used in knee arthroplasty, and their function is to restrict the flow of bone cement. The "Intended Use / Indications for Use" section lists patient conditions and surgical scenarios where the plugs might be used, but these are indications for the procedure or patients receiving the implant, not diagnostic functions of the device itself. The device itself is a surgical implant, not a diagnostic tool.
No
The device description explicitly states the device is manufactured from wrought titanium alloy and is a physical component (plug) designed to fit into a baseplate. 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 clearly describes the device as being used in vivo (within the body) for surgical procedures related to knee arthroplasty. It addresses patient conditions and surgical scenarios.
- Device Description: The device is a physical implant (tibial baseplate stem plugs) made of titanium alloy, designed to be surgically inserted into a patient's knee.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The tibial baseplate stem plugs are intended use in the following diagnostic indications:
- Patient conditions, including but not limited to, inflammatory degenerative joint -1. disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
- Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist.
- Revision of previously failed knee arthroplasty. 4.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Sulzer Orthopedics Apollo Revision/Constrained Knee Tibial Baseplate Stem Plugs ("plug"), manufactured from wrought (ASTM F136) titanium alloy, are designed to fit into the female connection of the baseplate keel when no tibial stem component is used. The plug is connected to the baseplate component via a small set screw. The plugs therefore act to restrict the flow of bone cement into the baseplate component is intended for use with the Apollo Revision/Constrained Knee Tibial Baseplate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analysis indicated that the device would survive physiologic loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(k) SUMMARY
K-983733
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Apollo Constrained/Revision Knee Tibial Baseplate Stem Plugs.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Date: | October 16, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC
Manager, Regulatory Affairs |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer/ metal/polymer 21 CFR 888.3560 |
| Common/Usual Name: | Knee Prosthesis, Partially Constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Apollo Constrained/Revision Knee System
Tibial Baseplate Stem Plugs |
PRODUCT DESCRIPTION
The Sulzer Orthopedics Apollo Revision/Constrained Knee Tibial Baseplate Stem Plugs ("plug"), manufactured from wrought (ASTM F136) titanium alloy, are designed to fit into the female connection of the baseplate keel when no tibial stem component is used. The plug is connected to the baseplate component via a small set screw. The plugs therefore act to restrict the flow of bone cement into the baseplate component is intended for use with the Apollo Revision/Constrained Knee Tibial Baseplate.
SPECIFIC DIAGNOSTIC INDICATIONS
The tibial baseplate stem plugs are intended for cemented use in the following diagnostic indications:
-
- Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
-
- Revision of previously failed knee arthroplasty.
SUBSTANTIAL EQUIVALENCE
The Sulzer Orthopedics Fluted Stems are substantially equivalent to stem plugs used with the Maxim Constrained Knee (Biomet), the Coordinate Revision Knee (DePuy), Kinemax Plus Super Stabilizer (Howmedica), and the PFC - TC3 (Johnson and Johnson).
Analysis indicated that the device would survive physiologic loading.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Mitchell A. Dhority, RAC Manager, Regulatory Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K983733 Re: Sulzer Orthopedics Apollo Trade Name: Constrained/Revision Knee System Tibial Baseplate Stem Pluqs Regulatory Class: II Product Code: JWH Dated: October 21, 1998 Received: October 22, 1998
Dear Mr. Dhority:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mitchell A. Dhority, RAC
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): k983 733
Device Name: Apollo Revision/Constrained Knee System Tibial Baseplate Stem Plug
Indications For Use:
The tibial baseplate stem plugs are intended use in the following diagnostic indications:
- Patient conditions, including but not limited to, inflammatory degenerative joint -1. disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
- Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist.
- Revision of previously failed knee arthroplasty. 4.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
holly
Prescription Use X
OR
Over-The-Counter Use
(Optional Format 1-2-96)