(216 days)
No
The summary describes a mechanical implant for 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 component of a total primary or revision shoulder joint replacement system, indicated for treating various conditions such as degenerative joint disease, fractures, and failed implants, which falls under the definition of therapeutic use.
No
Explanation: The device described is a shoulder joint replacement component (glenoid) intended for surgical implantation, not for diagnosing conditions. Its purpose is to treat existing conditions by replacing a joint, not to identify or assess them.
No
The device description clearly indicates it is a physical implantable device made of titanium alloy, intended for surgical use in shoulder replacement. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "total primary or revision shoulder joint replacement." This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of a shoulder implant (baseplate, peg, liner, screws, glenosphere) made from materials like titanium alloy. This aligns with a medical device for implantation, not an IVD.
- Performance Studies: The performance studies described are "fatigue resistance of the modular connection" and mechanical testing, which are relevant to the structural integrity of an implant, not the analytical performance of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the SMR TT Metal Back Glenoid is a surgical implant intended for use in shoulder replacement surgery.
N/A
Intended Use / Indications for Use
The SMR TT Metal Back 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);
When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid 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.
When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.
Product codes
PHX, KWS, KWS, KWT
Device Description
The SMR II Metal Back Glenoid is nearly identical to the design of the SMR Modular Glenoid component cleared for use in anatomic shoulder replacement as part of the SMR Anatomic Shoulder System (K113254) and for use in reverse shoulder replacement as part of the SMR Reverse Shoulder System (K110598) except that the subject device is a 2-piece modular rather than a 1-piece design. The subject TT Metal Back Glenoid consists of two (2) components, a baseplate and a peg, that are coupled together and placed in the prepared glenoid cavity. When used as part of the SMR Anatomic Shoulder System (K113254), the subject SMR TT Metal Back Glenoid attaches to the SMR Anatomic Shoulder System's Modular Glenoid Liner component and is intended for use with bone cement. When used with the SMR Reverse Shoulder System (K110598), the subject SMR TT Metal Back Glenoid attaches to the SMR Reverse Shoulder Glenosphere component (K110598) and is intended for uncemented fixation, with additional fixation provided by bone screws. In the SMR Reverse Shoulder System application, the SMR TT Metal Back Glenoid is attached to the SMR Reverse Shoulder Glenosphere using the connectors cleared in K110598.
Baseplates are made from Ti6Al4V and are available in three sizes (Small-R, Small and Standard) while Pegs are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). Pegs are characterized by a conical coupling to allow the connection with baseplates. They present a Trabecular Titanium structure on the external surface.
Liners to be used coupled to SMR TT Metal Backs in anatomic constructs have been cleared via K113254.These devices are intended articulate with previously cleared SMR standard or CTA humeral heads (K110858 and K110847).
Bone screws, Glenospheres and connectors have been cleared via KI 10598.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint
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
Non-Clinical Testing: The SMR TT Metal Back Glenoid was tested for fatigue resistance of the modular connection between the baseplate and the peg. The connection between the Metal Back and the Liner has not been changed from the one of the SMR Modular Glenoids. Mechanical testing was performed on worst case components or constructs. 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 TT Metal Back Glenoid to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
SMR Modular Glenoids (Limacorporate, K113254), Delta Xtend Reverse Shoulder System (DePuy, K120174), Aequalis Reversed Shoulder Prosthesis (Tomier, K100142-K081059).
Reference Device(s)
K113254, K110598, K110858, K110847
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized depiction of an 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 fashion around the emblem.
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. % Stephen J. Peoples, VMD, MS Peoples and Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K133349
Trade/Device Name: SMR TT Metal Back 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, KWS, KWT Dated: April 24, 2014 Received: May 2, 2014
Dear Dr. Peoples:
This letter corrects our substantially equivalent letter of June 3, 2014.
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
Page 2 - Stephen J. Peoples, VMD, MS
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): Unknown -K133349 Device Name: SMR TT Metal Back Glenoid Indications for Use:
SMR TT Metal Back Glenoid Indications for Use
The SMR TT Metal Back 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);
When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
JUN 0 3 2014
Summarv of Safety and Effectiveness
Date: October 8, 2013
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512
| Product | Common Name | Product Code | Regulation and Classification Name |
|---|---|---|---|
| SMR TT | |||
| Metal Back | |||
| Glenoid | Total or | ||
| Hemi | |||
| Shoulder | |||
| Prosthesis | KWS | Shoulder joint metal/polymer semi- | |
| constrained cemented prosthesis per 21 | |||
| CFR 888.3660 | |||
| KWT | Shoulder joint metal/polymer non- | ||
| constrained cemented prosthesis per 21 | |||
| CFR 888.3650 |
Description:
The SMR II Metal Back Glenoid is nearly identical to the design of the SMR Modular Glenoid component cleared for use in anatomic shoulder replacement as part of the SMR Anatomic Shoulder System (K113254) and for use in reverse shoulder replacement as part of the SMR Reverse Shoulder System (K110598) except that the subject device is a 2-piece modular rather than a 1-piece design. The subject TT Metal Back Glenoid consists of two (2) components, a baseplate and a peg, that are coupled together and placed in the prepared glenoid cavity. When used as part of the SMR Anatomic Shoulder System (K113254), the subject SMR TT Metal Back Glenoid attaches to the SMR Anatomic Shoulder System's Modular Glenoid Liner component and is intended for use with bone cement. When used with the SMR Reverse Shoulder System (K110598), the subject SMR TT Metal Back Glenoid attaches to the SMR Reverse Shoulder Glenosphere component (K110598) and is intended for uncemented fixation, with additional fixation provided by bone screws. In the SMR Reverse Shoulder System application, the SMR TT Metal Back Glenoid is attached to the SMR Reverse Shoulder Glenosphere using the connectors cleared in K110598.
Baseplates are made from Ti6Al4V and are available in three sizes (Small-R, Small and Standard) while Pegs are manufactured using an EBM (Electron Beam Melting) process
Traditional 510(k) - SMR TT Metal Back Glenoid
4
with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). Pegs are characterized by a conical coupling to allow the connection with baseplates. They present a Trabecular Titanium structure on the external surface.
Liners to be used coupled to SMR TT Metal Backs in anatomic constructs have been cleared via K113254.These devices are intended articulate with previously cleared SMR standard or CTA humeral heads (K110858 and K110847).
Bone screws, Glenospheres and connectors have been cleared via KI 10598.
Intended Use:
The SMR TT Metal Back 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);
When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid 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.
When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.
· Predicate Devices:
SMR Modular Glenoids (Limacorporate, K113254): Delta Xtend Reverse Shoulder System (DePuy, K120174); Aequalis Reversed Shoulder Prosthesis (Tomier, K100142-K081059).
Comparable Features to Predicate Device(s):
The SMR TT Metal Back Glenoid is similar to the predicate devices in terms of intended use, indications, design and materials. The SMR TT Metal Back Glenoid and the predicates are all intended for total primary or revision shoulder joint replacement.
Traditional 510(k) - SMR TT Metal Back Glenoid
5
Fixation methods for the SMR TT Metal Back Glenoid depend on whether it is being used with an Anatomic or Reverse Shoulder System. These fixation methods are similar to those for the predicate Anatomic and Reverse Shoulder Systems.
The SMR TT Metal Back Glenoid has a design which is similar to the metal-back glenoid of the SMR Modular Glenoid (K113254) except that the subject device is a 2-piece modular rather than a 1-piece design. Like the SMR Modular Glenoid (Limacorporate), the liner-metal back coupling is achieved through a snap-fit junction.
The components of the SMR TT Metal Back Glenoid are manufactured from the same or similar materials as the predicate devices.
Non-Clinical Testing:
The SMR TT Metal Back Glenoid was tested for fatigue resistance of the modular connection between the baseplate and the peg. The connection between the Metal Back and the Liner has not been changed from the one of the SMR Modular Glenoids. Mechanical testing was performed on worst case components or constructs. 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 TT Metal Back Glenoid to the predicate devices.