(71 days)
Not Found
Not Found
No
The document describes a mechanical implant (shoulder replacement) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a shoulder replacement, which is a medical implant intended to treat specific painful and disabling conditions of the shoulder, directly addressing a health problem.
No
The described device is a shoulder replacement system (bipolar or total shoulder replacement) and a humeral stem, indicated for treating various shoulder conditions post-diagnosis. It is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly indicates it is a physical implant (fracture humeral stem) and a line extension to existing shoulder replacement systems, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint due to various conditions like arthritis, necrosis, and fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a humeral stem, which is a component of a shoulder replacement system. This is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical strength of the components, which is relevant for a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
For use as a Bipolar Shoulder Replacement:
- 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 fractures and/or dislocation. .
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- . Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- 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 fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Product codes
87 KWS, 87 HSD
Device Description
This submission is a line extension to the Solar® Shoulder System for a fracture humeral stem. Fracture humeral stems will be based on the humeral component designs of the Solar® Shoulder, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System. The subject stems have suture holes and a bone-grafting window.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Solar® Shoulder Humeral Components, Solar® PureFix® HA Shoulder, Tornier Aequalis Shoulder Fracture System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K062/113
OCT - 3 2006
510(k) Summary of Safety and Effectiveness Solar" ReUnion™ Fracture Stem
| Proprietary Name: | Solar ReUnion™ Fracture Stem |
|---|---|
| Common Name: | Shoulder Prosthesis |
| Classification Name/Reference: | Shoulder joint metal/polymer semi constrained |
| cemented prosthesis. 21 CFR §888.3660 |
Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis. 21 CFR §888.3690 |
| Device Product Code: | 87 KWS, 87 HSD |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Francisco Haro, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5493 Fax: (201) 831-6038 |
| Date Summary Prepared: | July 21, 2006 |
Description
This submission is a line extension to the Solar® Shoulder System for a fracture humeral stem. Fracture humeral stems will be based on the humeral component designs of the Solar® Shoulder, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System. The subject stems have suture holes and a bone-grafting window.
Indications:
For use as a Bipolar Shoulder Replacement:
- 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 fractures and/or dislocation. .
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more . conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
1
- 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 fractures and/or dislocation. .
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or . other procedure.
Substantial Equivalence:
The Solar® ReUnion™ Fracture Stem is substantially equivalent to the Solar® Shoulder Humeral Components, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System in regards to intended use, design, materials, and operational principles as humeral components. The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure with three arms extending upwards, symbolizing growth and vitality. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2006
Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07432
Re: K062113
Trade/Device Name: Solar® ReUnion™ Fracture Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS and HSD Dated: July 21, 2006 Received: July 24, 2006
Dear Mr. Haro:
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.
3
Page 2 - Mr. Francisco Haro
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/industry/support/index.html.
Sincerely vours.
Barbara Buchner
for
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Solar® ReUnion™ Fracture Stem
Indications for Use:
For use as a Bipolar Shoulder Replacement:
- 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 fractures and/or dislocation. .
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- . Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- 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 fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (FULLOR W (Ju
(Division Sign-Off) Division of General, Restorative, and Neurologica: Devices
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510(k) Number K062113