(132 days)
Not Found
Not Found
No
The device description focuses on the materials and components of a knee replacement implant, with no mention of software, algorithms, or any technology related to AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a knee replacement system intended to treat painful osteo- or post-traumatic arthritis and unicompartmental osteoarthritis, which are medical conditions, thereby qualifying it as a therapeutic device.
No
This device is a knee replacement component, an orthopedic implant intended to replace damaged parts of the knee joint. It is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify a disease, condition, or state.
No
The device description clearly states it consists of physical components (distal femoral resurfacing component and proximal tibial resurfacing component) made of specific materials (cobalt-chromium alloy and ultra-high molecular weight polyethylene). This indicates it is a hardware medical device, not software-only.
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, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a surgical implant intended to replace parts of the knee joint. It is a physical component implanted into the body.
- Intended Use: The intended use describes treating joint disease and trauma through surgical replacement, not through laboratory testing of samples.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Moderately disabling joint disease of the knee resulting from painful osteo- or post ● traumatic arthritis.
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
Product codes (comma separated list FDA assigned to the subject device)
87 HSX
Device Description
This device consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only. The femoral component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-75. The tibial component is manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648.
The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. The subject components of the First Step Unicompartmental Knee System are single use devices which are sold sterile. The First Step Unicompartmental Knee System is intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint, femorotibial joint
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): 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.
Not Found
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
First Step Unicompartmental Knee System
510(k) Summary
ಕ್ಕೆ
9922
510(k) Summary
| Device: | First Step Unicompartmental Knee |
|---|---|
| Common Name: | Unicompartmental Knee System |
| Classification Name: | Knee joint femorotibial metal/ polymer non-constrained cemented |
| prosthesis 21 CFR §.888.3520 | |
| Regulatory Class: | Class II |
| Product Code: | 87 HSX |
| For Information contact: | Karen Ariemma, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| (201) 760-8187 | |
| Fax: (201) 934-4368 |
This device consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to be used to replace the medial or lateral compartments of the knee joint, specifically the femorotibial joint damaged as a result of inflammatory and non-inflammatory joint disease or trauma. These components are intended for cemented use only. The femoral component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-75. The tibial component is manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648.
The substantial equivalence of this device is based on equivalence in intended use, materials, design and operational principles to other predicate devices indicated for unicompartmental knee surgery. These devices include Howmedica Osteonics Corp.'s Duracon Unicompartmental Knee and SCR Uni Knee Systems.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be interconnected. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Terry Sheridan Powell Requlatory Affairs Team Stryker Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K992287 First Step Unicompartmental Knee System Trade Name: Regulatory Class: II Product Code: HSX September 13, 1999 Dated: Received: September 17, 1999
Dear Ms. Powell:
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 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 (Premarket Approval), 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 895. A 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 requlation (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.
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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 regulation (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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K 99 JJK 7
Device Name: Howmedica Osteonics® First Step Unicompartmental Knee System
The First Step Unicompartmental Knee System consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. The subject components of the First Step Unicompartmental Knee System are single use devices which are sold sterile. The First Step Unicompartmental Knee System is intended for cemented use only.
The specific indications and contraindications of the First Step Unicompartmental Knee System are stated in the following sections.
Indications
- Moderately disabling joint disease of the knee resulting from painful osteo- or post ● traumatic arthritis.
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use X OR
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Acosta