(87 days)
Not Found
No
The summary describes a mechanical knee prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a knee prosthesis, which is designed to treat painful and/or disabling knee joints due to various conditions, indicating a therapeutic purpose.
No
The described device is a knee prosthesis, which is a therapeutic device used to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly states it is a "prosthesis that replaces only one compartment of the knee condyles," indicating it is a physical implant, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Zimmer Unicompartmental Knee System is a prosthesis that replaces a part of the knee joint. This is an implantable device used in the body, not a device used to test samples from the body.
- Intended Use: The intended use describes the conditions for which the device is surgically implanted to treat knee problems. This is a therapeutic use, not a diagnostic use.
Therefore, the Zimmer Unicompartmental Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Product codes (comma separated list FDA assigned to the subject device)
IISX
Device Description
The Zimmer Unicompartmental Knee System (Zimmer Uni) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joints
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)
Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance procedure for the Zimmer Unicompartmental Knee System and FMEA demonstrated that this device is safe and effective and substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'Ko33363'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or generated with a slightly rough texture. The sequence consists of a mix of uppercase letters and numbers.
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter Z inside a circle on the left. To the right of the circle, there is some text, but it is too blurry to read clearly. The logo appears to be for a company or organization, but without clearer text, it's difficult to determine the exact nature of the business.
| JAN 1 6 2004 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Stephen McKelvey |
| Manager, Regulatory Affairs | |
| Telephone: (574) 372-4944 | |
| Fax: (574) 372-4605 | |
| Date: | October 17, 2003 |
| Trade Name: | Zimmer Unicompartmental Knee System |
| Common Name: | Unicompartmental Knee |
| Classification Name | |
| and Reference: | Knee joint femorotibial metal/polymer non- |
| constrained cemented prosthesis, 21 CFR § | |
| 888.3520 | |
| Predicate Device: | The predicate devices for the Zimmer |
| Unicompartmental Knee System are the | |
| Miller/Galante Precoat Unicompartmental Knee | |
| System, K880155 (cleared 8/3/88) and the | |
| Miller/Galante Precoat Unicompartmental | |
| Knee System (8 mm Articular Surface) Line | |
| Extension, K010685 (cleared 4/2/01). | |
| Device Description: | The Zimmer Unicompartmental Knee System |
| (Zimmer Uni) is a prosthesis that replaces only one | |
| compartment of the knee condyles. It is | |
| unconstrained in the anteroposterior and | |
| mediolateral directions and also allows | |
| unconstrained internal/external rotation between the | |
| femoral and tibial components. This movement is | |
| limited only by the ligaments and other soft tissues | |
| surrounding the device. | |
| Intended Use: | These devices are indicated for patients with: |
| - Painful and/or disabling knee joints due to | |
| osteoarthritis or traumatic arthritis. | |
| - Previous tibial condyle or plateau fractures | |
| with loss of anatomy or function. |
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only. |
| | The Zimmer Unicompartmental Knee System is
designed for use when load bearing ROM is
expected to be less than or equal to 155 degrees. |
| Comparison to Predicate Device: | The Zimmer Unicompartmental Knee System is
substantially equivalent to the Miller/Galante
Precoat Unicompartmental Knee System in that
both have similar indications, design (both are non-
constrained, unicompartmental knee prostheses),
materials and mechanical safety. Both devices are
intended for cemented use only. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design
assurance procedure for the Zimmer Unicompart-
mental Knee System and FMEA demonstrated that
this device is safe and effective and substantially
equivalent to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
this device. |
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Image /page/1/Picture/1 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside of a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Mr. Stephen McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K033363
Trade/Device Name: Zimmer Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint Femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: IISX Dated: October 17, 2003 Received: October 21, 2003
Dear Mr. McKelvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device wforenced 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 conniner of prox to 114) works 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). and Cosmetre for (. market the device, subject to the general controls provisions of the Act. The r ou may, morely inims of the Act include requirements for annual registration, listing of general ocurem proficturing 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 If your device to such additional controls. Existing major regulations affecting your device can may or satifyer to basil at and Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actives and 1197 birding that your device complies with other requirements of the Act that I Dri has intact a actuations administered by other Federal agencies. You must or uny I vith 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 CFR in the quality systems (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality of the Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Stephen McKelvey
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter with anow you to begin manteans your must of your device of your device to a legally premaired 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 If you desire specific advice for your as 1100 of the states note the regulation entitled, the regulation entitled, Collider the Oriece or Compuner and market notification" (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premessoonsibilities under the Act from the Division of Small other general informational 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,
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
4
K033363
Indications for Use
510(k) Number (if known): | 033363
Device Name:
Zimmer Unicompartmental Knee System
Indications for Use:
These devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. ।
- Previous tibial condyle or plateau fractures with loss of anatomy or function. -
- Varus or valgus deformities. 。
- Revision of previous arthroplasty procedures. -
These devices are indicated for cemented use only.
The Zimmer Unicompartmental Knce System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cllayl
ion of General, Restorative Choice Boy
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Number K03363