(323 days)
Predicate Device(s): The total system will over manufactured from the exact same materials as the predicate devices.
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to replace parts of the shoulder joint to relieve pain and reconstruct the joint for normal function, which are therapeutic purposes.
No
Explanation: The Javelin Shoulder is an orthopedic implant (shoulder replacement system) intended for surgically replacing the humeral head and/or glenoid to relieve pain and reconstruct the joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly indicates it is a physical implant (humeral head, glenoid component) made from materials, intended for surgical implantation. It is not software.
Based on the provided information, the Javelin Shoulder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The Javelin Shoulder is an implantable device intended to replace parts of the shoulder joint. It is used in the body, not to test samples from the body.
- The intended use and device description clearly describe a surgical implant. The purpose is to replace bone and reconstruct the joint, not to diagnose a condition based on laboratory analysis.
The description aligns with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is meant to replace the natural humeral head and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cemented and uncemented use. The glenoid component is for cemented use only.
The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include:
- · Aseptic necrosis of the humeral head.
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Proximal humeral fracture and/or dislocation.
- · Clinical management problems where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results.
Additional indications for use as a total shoulder include:
- · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Product codes
87 KWS, 87 HSD
Device Description
The Javelin Shoulder is a fully anatomic design with an articulating humcral head that will allow it to be placed in the same position as the resected native humeral head. It will allow for variable adjustments for neck angle as well as varus/valgus variances in the neck resection. The humeral heads will be available in multiple diameters and head heights in order to better replicate the normal anatomic range of sizes in patient anatomy.
The total system will consist of an array of sizes of humeral components, humeral heads, The total system will over manufactured from the exact same materials as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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
Testing was performed to determine the subject components met the performance criteria.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
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JAN - 7 2005
510(k) Summary of Safety and Effectiveness for the JAVELIN SHOULDER
| Proprietary Name: | Javelin Shoulder |
|---|---|
| Common Name: | Artificial Shoulder Humeral Components |
| Classification Name and Reference | Shoulder joint metal/polymer semi- |
| constrained cemented prostheses, 21 CFR | |
| §888.3660 | |
| or | |
| Shoulder joint humeral (hemi-shoulder) | |
| metallic uncemented prostheses, 21 CFR | |
| §888.3690 | |
| Regulatory Class: | Class II for §888.3660 |
| Class II for §888.3690 | |
| Device Product Code: | 87 KWS: prosthesis, shoulder, semi- |
| constrained, metal/polymer cemented | |
| 87 HSD: prosthesis, shoulder, hemi-, | |
| humeral, metallic uncemented | |
| For Information contact: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| Phone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| E-Mail: Karen.ariemma@stryker.com | |
| Date Summary Prepared: | January 5, 2005 |
Device Description
The Javelin Shoulder is a fully anatomic design with an articulating humcral head that will allow it to be placed in the same position as the resected native humeral head. It will allow for variable adjustments for neck angle as well as varus/valgus variances in the neck resection. The humeral heads will be available in multiple diameters and head heights in order to better replicate the normal anatomic range of sizes in patient anatomy.
1
The total system will consist of an array of sizes of humeral components, humeral heads, The total system will over manufactured from the exact same materials as the predicate devices.
Intended Use:
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is meant to replace the natural humeral hcad and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cemented and uncemented use. The glenoid component is for cemented use only.
The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include:
- · Aseptic necrosis of the humeral head.
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Proximal humeral fracture and/or dislocation.
- · Clinical management problems where arthrodesis or alternative reconstruction techniques are
less likely to achieve satisfactory results.
Additional indications for use as a total shoulder include:
- · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Substantial Equivalence:
The features of the Javelin Shoulder are substantially equivalent to the corresponding features of the predicate components. Testing was performed to determine the subject components met the performance criteria. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.
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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 & 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 image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahway. New Jersey 07430
Re: K040432 Trade/Device Name: Javelin Shoulder Regulation Number: 21 CFR 888.3660, 21 CFR 888.3690 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis, Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: October 13, 2004 Received: October 14, 2004
Dear Ms. Ariemma:
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 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.
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Page 2 – Ms. Karen Ariemma
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 (240) 276-0120. 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,
Ula wto
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
510(k) Number (if known): ___K040432
Device Name: Javelin Shoulder
The Javelin Shoulder is intended for use in total and hemi-arthroplasty of the shoulder. It is r he suvelin bhouted is now humeral head and/or glenoid to relieve pain and reconstruct the joint to re-establish as much normal joint function as possible. The humeral component is for cere othed and uncemented use. The glenoid component is for cemented use only.
The indications for use of the Javelin Shoulder when used as a total or hemi-shoulder include:
- · Aseptic necrosis of the humeral head.
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Proximal humeral fracture and/or dislocation.
- · Clinical management problems where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results.
Additional indications for use as a total shoulder include:
- · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
Division Sign Off
Division of General, Restorative. and Neurological Devices
510(k) Number K040432