(33 days)
Not Found
No
The document describes a physical orthopedic implant and its materials, intended use, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a glenoid shoulder component intended for use in total shoulder arthroplasty to treat painful and disabling joint diseases, restore function, and alleviate pain, which are all therapeutic outcomes.
No
The device is a glenoid shoulder component for total shoulder arthroplasty, which is a treatment device, not a diagnostic one. Its purpose is to replace a diseased or damaged joint, not to identify a medical condition.
No
The device description clearly states the device is a physical component manufactured from UHMWPE and cobalt chromium alloy, intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Special Orthopaedic Solutions Glenoid Shoulder Component is a surgical implant intended for cemented fixation within the prepared glenoid fossa of the shoulder. It is used in total shoulder arthroplasty to replace a damaged joint.
- Lack of Diagnostic Activity: The device does not perform any tests on bodily samples to diagnose a condition. Its function is purely mechanical and structural, replacing a damaged part of the body.
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
The Special Orthopaedic Solutions Glenoid Shoulder Component is a single use device intended for cemented fixation within the prepared glenoid fossa of the shoulder.
The indications for use of the total shoulder arthroplasty 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.
. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
The glenoid components are intended for cemented use only.
Product codes
87 KWS, KWS
Device Description
The Special Orthopaedic Solutions Glenoid Shoulder Component is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from ASTM F-648 ultra high molecular weight polyethylene (UHMWPE) and features an xray marking wire on its medial surface manufactured from ASTM F-90 cobalt chromium alloy. The glenoid component will be offered in three sizes 5, 7, & 9 with a 10 degree posterior buildup. Additional size 9 glenoid components both with and without posterior buildup will also be offered with new peg geometry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glenoid fossa of the 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)
Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing includes dynamic evaluation of glenoid loosening via ASTM F2028-08 and an engineering analysis on the polyethylene thickness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 888.3660 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.”
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510(k) Summary of Safety and Effectiveness: SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
NOV 2 2 2010
| Proprietary Name: | Special Orthopaedic Solutions Glenoid |
|---|---|
| Shoulder Component Common Name: | Total Joint Shoulder Component |
| Classification Name and Reference: | Shoulder Joint Metal/Polymer Semi- |
| Constrained Cemented Prosthesis 21 CFR | |
| §888.3660 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 KWS |
| For Information contact: | Avital Merl-Margulies |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Prepared: | 11/22/2010 |
Description:
The Special Orthopaedic Solutions Glenoid Shoulder Component is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from ASTM F-648 ultra high molecular weight polyethylene (UHMWPE) and features an xray marking wire on its medial surface manufactured from ASTM F-90 cobalt chromium alloy. The glenoid component will be offered in three sizes 5, 7, & 9 with a 10 degree posterior buildup. Additional size 9 glenoid components both with and without posterior buildup will also be offered with new peg geometry.
Intended Use:
The Special Orthopaedic Solutions Glenoid Shoulder Component is a single use device intended for cemented fixation within the prepared glenoid fossa of the shoulder.
1
Indications for Use:
The indications for use of the total shoulder arthroplasty 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.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
The glenoid components are intended for cemented use only.
Proposed Modification:
The subject Special Orthopaedic Solutions Glenoid Shoulder Component has the same indications for and intended use, material, operational principles, and bearing sizes as the previously cleared Osteonics All Polyethylene Glenoid Shoulder Component cleared under K950521. The subject Special Orthopaedic Solutions Glenoid Shoulder Component device consists of a rotation to the bearing surface of the implant to increase the posterior thickness to help restore joint alignment. Additional size 9 glenoid components both with and without posterior buildup will also be offered with a modified peg geometry.
Summary of Data:
Testing has been performed to demonstrate equivalence of the subject device to its predicate device. The testing includes dynamic evaluation of glenoid loosening via ASTM F2028-08 and an engineering analysis on the polyethylene thickness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
NOV 2 2 2010
Re: K103104
Trade/Device Name: Specia! Orthopaedic Solutions Glenoid Shoulder Component Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: October 14, 2010 Received: October 20, 2010
Dear Ms. Merl-Margulies:
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Ms. Avital Merl-Margulies
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
For Ato
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k)
Special Orthopaedic Solutions Glenoid Skoulder Component
Indications for Use
NOV 2 2 2010
510(k) Number (if known): K103104
Device Name: Special Orthopaedic Solutions Glenoid Shoulder Component
Indications for Use:
The indications for use of the total shoulder arthroplasty 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. .
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other 。 procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
The glenoid components are intended for cemented use only.
| 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
OF NEEDED)
Concurrence of DRBFC Office of Detice Evaluation (ODE)
Page I of 1
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103104
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