(100 days)
Not Found
No
The document describes a mechanical implant (shoulder system) and its components, with no mention of software, algorithms, or data processing that would suggest AI/ML. The testing described is mechanical, not related to algorithmic performance.
Yes
The device is a glenoid component for shoulder joint replacement, which is indicated for treating conditions like osteoarthritis, avascular necrosis, and fractures, all of which aim to alleviate symptoms and restore function.
No
The device description clearly states it is a prosthetic implant for shoulder joint replacement, not a tool for diagnosis. Its purpose is to treat conditions, not to identify them.
No
The device description clearly states it is a physical implant (UHMWPE glenoids) for shoulder replacement surgery, 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 describes a surgical implant for replacing parts of the shoulder joint in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a shoulder implant (glenoids made of UHMWPE) designed for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing and range of motion, which are relevant to the function of a surgical implant, not a diagnostic test.
IVD devices are used outside the body to examine specimens from the body. This device is implanted inside the body to replace a joint.
N/A
Intended Use / Indications for Use
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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).
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 (disabled 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.
The SMR 3-Pegs Glenoids are available in four sizes: size Small and Standard have been previously cleared for market via premarket notification K130642. The only difference between the subject SMR 3-Pegs Glenoids and those cleared via K130642 is the size offering: the subject device is offered in size Extra-Small and Large.
The SMR 3-Pegs Glenoids are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.
The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Static Evaluation of the Glenoid Locking Mechanism in Shear (ASTM F1829);
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028):
- Range of motion (ASTM F1378).
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR 3-Pegs Glenoids to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K130642, K100858 / K101263 / K110847 / K111212, K113254
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.
Not Found
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.”
0
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 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, stacked on top of each other.
April 6, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Limacorporate S.p.A. % Dr. Stephen Peoples President Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K153722
Trade/Device Name: SMR 3-Pegs Glenoids Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: March 3, 2016 Received: March 9, 2016
Dear Dr. Peoples:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153722
Device Name SMR 3-Pegs Glenoids
Indications for Use (Describe)
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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).
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 (disabled 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
| System | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not Cem | ||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | Humeral Extension | Ti6Al4V | X | X |
| • | • | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X |
| • | • | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| • | • | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | SMR Glenospheres | CoCrMo | X | |
| • | • | SMR Connectors | Ti6Al4V | X | |
| • | • | Reverse Liners | UHMWPE | X | X |
| • | SMR Cemented Glenoids | UHMWPE | X | ||
| • | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | ||
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| • | • | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| • | SMR TT Metal Back Peg | Ti6Al4V | X | X | |
| • | SMR Metal Back Liner | UHMWPE | X* | X* | |
| •* | SMR Bone screws | Ti6Al4V | X |
FORM FDA 3881 (8/14)
EF PSC Publishing Services (301) 443-6740
3
A= Anatomic / R=Reverse
*NOTE :
· 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 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.
· In the US the SMR TT Metal Back Glenoid used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
Summary of Safety and Effectiveness
Date: April 5th, 2016
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 | Product Code | Regulation and Classification Name |
|---|---|---|
| SMR 3-Pegs Glenoids | KWS | Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis per 21 CFR 888.3660 |
Description
The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.
The SMR 3-Pegs Glenoids are available in four sizes: size Small and Standard have been previously cleared for market via premarket notification K130642. The only difference between the subject SMR 3-Pegs Glenoids and those cleared via K130642 is the size offering: the subject device is offered in size Extra-Small and Large.
The SMR 3-Pegs Glenoids are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.
The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.
Intended Use
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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). ●
Traditional 510(k) - SMR 3-Pegs Glenoids April 5th, 2016
5
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 (disabled 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
| System | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not | ||
| Cem | |||||
| ● | ● | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| ● | ● | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| ● | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X | |
| ● | SMR Reverse Humeral Body | Ti6Al4V | X | X | |
| ● | ● | Humeral Extension | Ti6Al4V | X | X |
| ● | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X | |
| ● | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X | |
| ● | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X | |
| ● | SMR Glenospheres | CoCrMo | X | ||
| ● | SMR Connectors | Ti6Al4V | X | ||
| ● | Reverse Liners | UHMWPE | X | X | |
| ● | SMR Cemented Glenoids | UHMWPE | X | ||
| ● | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | ||
| ● | ● | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| ● | ● | SMR TT Metal Back Peg | Ti6Al4V | X | X |
| ● | ● | SMR Metal Back Liner | UHMWPE | X* | X* |
| • * | ● | SMR Bone screws | Ti6Al4V | X | |
| Material Standards | |||||
| Ti6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - | |||||
| PoroTi Titanium Coating (ASTM F1580) |
A= Anatomic / R=Reverse
*NOTE :
- . 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.
Traditional 510(k) - SMR 3-Pegs Glenoids April 5th, 2016
6
- . 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.
- In the US the SMR TT Metal Back Glenoid used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
Predicate Devices
- SMR 3-Pegs Glenoids (Limacorporate, K130642);
- SMR Cemented Glenoids (Limacorporate, K100858 / K101263 / K110847 / K111212);
- SMR Liners L1 for Metal Back Glenoids (Limacorporate, K113254).
Comparable Features to Predicate Device(s):
The intended use, design, and materials of the SMR 3-Pegs Glenoids are substantially equivalent to the ones of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Non-clinical testing
Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Static Evaluation of the Glenoid Locking Mechanism in Shear (ASTM F1829);
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028):
- Range of motion (ASTM F1378). ●
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR 3-Pegs Glenoids to the predicate devices.