(323 days)
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.
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.
This 510(k) summary describes the Javelin Shoulder, an artificial shoulder humeral component. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with a detailed statistical analysis of device performance.
Therefore, many of the requested elements for describing acceptance criteria and a study proving their fulfillment are not present in this document. The document describes the device, its intended use, and states that testing was performed to determine the components met performance criteria, but it does not elaborate on these criteria or the study details.
Here's a breakdown of the available and missing information based on your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Testing was performed to determine the subject components met the performance criteria. (Details of criteria and specific performance outcomes are not provided). |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified. The document refers to "testing" but does not provide details on the number of components or the nature of the tests (e.g., mechanical, simulated use).
- Data provenance: Not applicable in the context of human data. The "testing" mentioned would likely involve mechanical and materials testing of the device components, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a medical device submission for an orthopedic implant, not an AI/diagnostic device that requires expert-established ground truth from medical images or clinical evaluations. The "truth" here would pertain to the mechanical and material specifications of the implant.
4. Adjudication method for the test set
- Not applicable. (See answer to #3.)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a physical medical device (shoulder implant), not a diagnostic device or AI software that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. (See answer to #5.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the "testing" mentioned. For a physical implant, ground truth would typically refer to established engineering specifications, material properties, and biomechanical performance standards that the device needs to meet.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. The "training set" concept does not apply.
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8.)
Summary of what the document does provide regarding device performance:
The document states: "Testing was performed to determine the subject components met the performance criteria." It also emphasizes that the "intended use, material, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical." This suggests that the performance criteria are primarily related to the mechanical and material characteristics of the implant, demonstrating that the Javelin Shoulder performs equivalently to its predicate devices, which are already legally marketed. For implants, performance criteria would typically include:
- Mechanical strength and fatigue: Ensuring the implant can withstand physiological loads over time without failure.
- Material biocompatibility: Confirming the materials are safe for implantation in the human body.
- Dimensional accuracy: Verifying that the components conform to design specifications.
- Sterility assurance: Confirming effective sterilization methods.
However, the specific tests conducted, the acceptance values for these tests, and the actual results are not detailed in this 510(k) summary. The purpose of a 510(k) summary is to summarize the safety and effectiveness information, not to provide full study reports.
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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 §888.3660Class 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 AriemmaRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07430Phone: (201) 831-5718Fax: (201) 831-6038E-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.
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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
§ 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.