(86 days)
K/DEN: Not Found
Not Found
No
The summary describes a physical medical device (tibial inserts) made of UHWMPe, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a component of a knee replacement system used to treat degenerative joint diseases, which falls under restorative or reconstructive purposes rather than directly administering therapy.
No
The device description clearly states that these are "Tibial Inserts" made of "Ultra High Molecular Weight Polyethylene," indicating they are an implantable prosthetic component for knee arthroplasty, not a diagnostic tool. The "Intended Use / Indications for Use" section lists patient conditions that might lead to the need for such an implant, but the device itself does not perform diagnosis.
No
The device description explicitly states the device is manufactured from Ultra High Molecular Weight Polyethylene (UHWMPe) and is a physical implant (tibial insert). It does not mention any software components.
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 for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that this device is a tibial insert made of Ultra High Molecular Weight Polyethylene (UHWMPe). It is a physical implant used in knee replacement surgery.
- Intended Use: The intended use describes the patient conditions for which the knee replacement is indicated (e.g., inflammatory degenerative joint disease, failed previous surgery). It does not describe a diagnostic test performed on a sample.
- Lack of Diagnostic Testing: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
This device is a surgical implant used to replace a damaged part of the knee joint, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Sulzer Orthopedics P.S. Condylar Tibial Inserts 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.
The Natural-Knee II P.S. Condylar Tibial Inserts are intended for 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. 2.
- Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist.
- Revision of previously failed knee arthroplasty. 4.
Product codes
JWH
Device Description
The Sulzer Orthopedics P.S. Condylar Tibial Inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHWMPe) conforming to ASTM F648. The Condylar Inserts are asymmetric; therefore they are available in left and right orientations. The inserts are available in three sizes 00/0, 1/2, and 3/4/5) and seven thicknessses (9, 11, 13, 16, 19, 22, and 25). This device is intended for use with the following devices:
- Natural-Knee® II Constrained Femoral Component. These tibial inserts cannot be used with any other femoral components
- . Natural-Knee® II Constrained Knee Tibial Baseplate
- Natural-Knee® II System Tibial Baseplate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the Natural-Knee® II Constrained Knee Tibial Inserts, the Natural-Knee® II P.S. Tibial Inserts, and the Apollo" Constrained/Revision Knee Tibial Inserts.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Natural-Knee II Posterior Stabilized Condylar Insert.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| Date: | August 25, 1998 |
| Contact Person: | Mitchell 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 Natural-Knee® II Posterior Stabilized (P.S.)
Condylar Tibial Inserts |
PRODUCT DESCRIPTION
The Sulzer Orthopedics P.S. Condylar Tibial Inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHWMPe) conforming to ASTM F648. The Condylar Inserts are asymmetric; therefore they are available in left and right orientations. The inserts are available in three sizes 00/0, 1/2, and 3/4/5) and seven thicknessses (9, 11, 13, 16, 19, 22, and 25). This device is intended for use with the following devices:
- Natural-Knee® II Constrained Femoral Component. These tibial inserts cannot be used with any other femoral components
- . Natural-Knee® II Constrained Knee Tibial Baseplate
- Natural-Knee® II System Tibial Baseplate.
SPECIFIC DIAGNOSTIC INDICATIONS
The Sulzer Orthopedics P.S. Condylar Tibial Inserts 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 P.S. Condylar Tibial Inserts are substantially equivalent to the following: the Natural-Knee® II Constrained Knee Tibial Inserts, the Natural-Knee® II P.S. Tibial Inserts, and the Apollo" Constrained/Revision Knee Tibial Inserts.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a bird in flight, composed of curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Ms. Denise Duchene Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K983153 Re: Sulzer Orthopedics Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts Regulatory Class: II Product Code: JWH Dated: September 8, 1998 Received: September 9, 1998
Dear Ms. Duchene:
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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your device subject to cement." the general controls provisions of the Act and the following limitations:
- The thinnest tibial insert available is the nominal "9 1. mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.00 mm.
-
- This device may not be labeled or promoted for noncemented use.
-
- All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
- 4 . Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under
2
Page 2 - Ms. Denise Duchene
21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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
3
Page 3 - Ms. Denise Duchene
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
4
Page 1 of 1
510(k) Number (if known):
Device Name: Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts
Indications For Use:
The Natural-Knee II P.S. Condylar Tibial Inserts are intended for 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. 2.
- 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)
| Prescription Use | |
|---|---|
| ------------------ | -------------------- |
OR
| Over-The-Counter Use | (Optional Format 1-2-96) | |
|---|---|---|
| (Division Sign-Off) Division of General Restorative Devices | ||
| 510(k) Number | 1983153 |