(90 days)
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Not Found
No
The device description and intended use are purely mechanical components for knee replacement, with no mention of software, algorithms, or data processing.
Yes
The device, a tibial spacer, is intended for use in total knee arthroplasty to treat conditions like degenerative and inflammatory joint diseases, and to correct deformities, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a tibial spacer, an orthopedic implant used in total knee arthroplasty, not a diagnostic tool. Its purpose is to replace part of a joint, not to identify or characterize a disease or condition.
No
The device description clearly states the device is a physical component (Tibial Spacer) manufactured from cobalt chrome alloy, intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a tibial spacer, which is a physical implant made of cobalt chrome alloy. It is intended to be surgically implanted into the knee joint during total knee arthroplasty.
- Intended Use: The intended use is for the surgical treatment of knee conditions like osteoarthritis and rheumatoid arthritis by replacing damaged joint components. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Tibial Spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- . Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;
- Correctable valgus-varus deformity and moderate flexion contracture. .
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
Product codes
HRY, JWH
Device Description
These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.
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 joint
Indicated Patient Age Range
skeletally mature individuals
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
Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
031183
510(k) SUMMARY
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 432-9324
Robert.Wolfarth@Centerpulse.com |
| TRADE NAME: | Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate |
| COMMON NAME: | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| CLASSIFICATION: | Knee joint femorotibial metal/polymer semi-constrained cemented prostheses (Product Code 87 HRY) are Class II per 21 CFR §888.3530, reviewed by the Orthopedic Devices panel. |
PREDICATE DEVICE:
The new Tibial Spacer is substantially equivalent to the Centerpulse Orthopedics Natural-Knee® System Tibial Spacer.
DEVICE DESCRIPTION:
These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.
INTENDED USE:
The Tibial Spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- . Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;
- Correctable valgus-varus deformity and moderate flexion contracture. .
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device.
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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 or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2003
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K031183 Trade/Device Name: Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 14, 2003 Received: April 15, 2003
Dear Mr. Wolfarth:
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
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Page 2 - Mr. Robert M. Wolfarth
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stypt Rlwels
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
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Indications For Use
KO31183 510(K) Number:
Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate Device Name:
Indications for Use:
The tibial spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;
- Correctable valgus-varus deformity and moderate flexion contracture.
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
Division of General, Restorative and Neurological Devices
510(k) Number K031187
(Optional Format 1-2-96)