(113 days)
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No
The document describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a component of a shoulder joint replacement system, intended to treat conditions like degenerative joint disease, fractures, and failed implants, which clearly falls under the definition of a therapeutic intervention.
No
The provided text describes a medical device, the SMR Modular Glenoid, which is an implant used in shoulder joint replacement surgery. The 'Intended Use / Indications for Use' section clearly states its purpose is for treatment of various shoulder conditions and revision of failed implants. There is no mention of the device being used to identify, detect, or monitor a medical condition, disease, or risk factor. Its function is entirely therapeutic/reconstructive rather than diagnostic.
No
The device description clearly states it consists of physical components made of metal and plastic (metal-back, liner, bone screws) intended for surgical implantation in the shoulder joint. It does not describe any software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The SMR Modular Glenoid is a physical implant intended for surgical use in replacing a shoulder joint. It is a mechanical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the SMR Modular Glenoid is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system.
The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Inflammatory degenerative joint disease such as rheumatoid arthritis; ●
- Treatment of acute fractures of the humeral head that cannot be treated with other . fracture fixation methods;
- Revision of a failed primary implant; ●
- Cuff tear arthropathy (CTA Heads only); .
In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR Metal Backed Glenoid/Connector/Glenosphere construct. used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The SMR Modular Glenoid consists of a metal-back and a liner; when used without cement, bone screws are used for additional fixation. These components are used in total shoulder replacements: the SMR Modular Glenoid metal-backs can be used either in anatomical replacement (when coupled with SMR Modular Glenoid liners) or in reverse replacement (when coupled with previously cleared glenospheres and connectors). The SMR Metal Backed Glenoid and Liner construct, when used as part of a SMR Anatomic Shoulder Replacement is intended for use with bone cement and should be used without bone screws. The SMR Metal Backed Glenoid, Connector and Glenosphere construct, when used as part of a SMR Reverse Shoulder Replacement is intended for uncemented use with the addition of screws for fixation. The size large metal back is not suitable for coupling with 36 mm concentric glenosphere.
Metal-backed glenoids are made from Ti6A14V. The backside surface of the metal-back is plasma spray titanium coated. Four sizes (small, Standard and Large) are available.
Liners are manufactured from UHMWPE. In anatomical replacement, these devices are intended to be coupled with the SMR Modular Glenoid metal-backs and articulate with previously cleared SMR standard or CTA humeral heads. Liners are available in four sizes (small-R, Small, Standard and Large).
The liner articulating surface has a radius of curvature greater than the corresponding humeral head allowing translation in the superior/inferior and anterior/posterior directions. The SMR system has no restriction in regard to the pairing of different sizes of humeral heads and glenoid components. Each humeral head size can be combined with each glenoid size.
Bone screws are manufactured from titanium alloy Ti6AI4V (ASTM F1472 - ISO 5832-3). Bone screws have a diameter of 6.5 mm and are available in lengths from 20 to 40 mm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The SMR Modular Glenoid was tested in static shear and dynamic testing. The plasma spray titanium coating was tested in adhesion, shear, shear fatigue and abrasion testing. A Range of Motion simulation has been performed to ensure the device design does not overly limit range of motion. All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Modular Glenoid to the predicate devices.
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.
K110598, K100858, K101263, K110847, K111212, K030710, K992119, K081448
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).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Limacorporate S.p.A. % Ms. Cheryl Hastings Hastings Regulatory Consulting, LLC P.O. Box 696 Winona Lake, Indiana 46590-696
Re: K113254 Trade/Device Name: SMR Modular Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: February 21, 2012 Received: February 22, 2012
Dear Ms. Hastings:
This letter corrects our substantially equivalent letter of February 24, 2012.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Unknown Device Name: SMR Modular Glenoid Indications for Use: