(158 days)
Not Found
No
The document describes a shoulder implant system and its components, focusing on materials, sterilization, and intended use for joint replacement. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
This device is an implant for shoulder joint replacement, which is a surgical intervention rather than a therapeutic device that directly treats a condition without replacement. While it addresses the symptoms and disability, it does so through mechanical replacement, not active therapy.
No
The SMR Shoulder System is a shoulder joint replacement system, designed for surgical implantation. It is a therapeutic device, not a diagnostic one. Its intended use is to replace failed or diseased joint components, not to identify or characterize a medical condition.
No
The device description clearly states it is a shoulder system composed of physical components like glenoid baseplates and pegs made from materials such as UHMWPE, Tantalum, and Ti6Al4V. It also discusses sterilization methods for these physical components. There is no mention of software as the primary or sole component of the device.
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 a shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a shoulder prosthesis. It does not mention any reagents, test kits, or methods for analyzing biological samples.
- Lack of Diagnostic Language: The text does not use any language associated with diagnostics, such as "diagnosis," "detection," "measurement," "analysis of biological samples," or "in vitro."
- Focus on Surgical Procedure: The indications for use and device description are entirely focused on the surgical implantation and function of the shoulder system within the body.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an in vivo (within the body) implant.
N/A
Intended Use / Indications for Use
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
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; in case of SMR Short Stems only if sufficient bone stock remains);
- cuff tear arthropathy (CTA Heads only); .
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of 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 with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
Product codes
KWS, KWT, MBF, PHX
Device Description
The SMR Shoulder System is a shoulder system. The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are glenoid components intended to be used in combination with the previously cleared components of the SMR Shoulder System (humeral stems, humeral bodies, adaptor tapers, humeral heads) to achieve an anatomic configuration.
The purpose of the Special 510(k) is to add an alternative sterilization method for SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.
The SMR TT Hybrid Glenoid is composed by a poly baseplate and a peg. The poly baseplate is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648) and Tantalum (ISO 13782 ASTM F560). The peg is manufactured from Ti6Al4V (ISO 5832-3 ASTM F1472).
The SMR 3-Pegs Cemented Glenoid is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648).
The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid can be sterilized using a minimum gamma radiation dose of 25 kGy.
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)
Preclinical Testing:
The following activities were performed:
- Sterilization validation
- Packaging validation
- UHMWPE Characterization
Clinical Testing:
Clinical testing was not necessary to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2022
LimaCorporate S.p.A % Lacey Harbour Sr. Regulatory and Quality Manager US Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, Texas 76006
Re: K213785
Trade/Device Name: SMR TT Hybrid Glenoid. SMR 3-Pegs Cemented Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, KWT, MBF, PHX Dated: December 2, 2021 Received: December 6, 2021
Dear Lacey Harbour:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lixin Liu, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213785
Device Name SMR TT Hybrid Glenoid
SMR 3-Pegs Cemented Glenoid
Indications for Use (Describe)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
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; in case of SMR Short Stems only if sufficient bone stock remains);
- cuff tear arthropathy (CTA Heads only); .
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of 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 with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | • | SMR Short Stems (Cementless Finned) | 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 |
3
| ● | ● * | SMR TT Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
|---|---|---|---|---|---|
| ● | ● | SMR TT Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | X | |
| ● | ● | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| ● | ● | SMR TT Augmented 360 Baseplate | Ti6Al4V | X | |
| ● | ● | SMR TT Glenoid 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) - Ta (ISO13782 - ASTM F560)
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.
- . SMR Lateralized Connectors are not indicated for use with glenoid bone grafting techniques.
- . In the US the SMR TT Metal Back Baseplate 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.
- . If a SMR TT Hybrid Glenoid is in place and reverse prosthesis is required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR TT Hybrid Glenoid Reverse Baseplate. The SMR TT Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
- . The Dia. 50, 52 and 54mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
| 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) |
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4
| 510(k) number: | K213785 |
|---|---|
| Device Trade Name: | SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented |
| Glenoid | |
| Manufacturer: | LimaCorporate S.p.A |
| Via Nazionale, 52 | |
| 33038 Villanova di San Daniele del Friuli | |
| Udine, Italy | |
| Contact: | Mr. Roberto Gabetta |
| Regulatory Manager | |
| Phone: +39 338 6439379 | |
| Email: roberto.gabetta@limacorporate.com | |
| Prepared by: | Mrs. Lacey Harbour |
| Sr. Regulatory and Quality Manager US | |
| Lima USA Inc. | |
| Office Phone: 817.385.0777 ext.200 | |
| Cell Phone: 432.638.6615 | |
| FAX: 817.385.0377 | |
| lacey.harbour@limacorporate.com | |
| Date Prepared: | May 13, 2022 |
| Classification: | 21 CFR 888.3660 Shoulder joint metal/polymer semi- |
| constrained cemented prosthesis. | |
| 21 CFR 888.3650 Shoulder joint metal/polymer non- | |
| constrained cemented prosthesis. | |
| 21 CFR 888.3670 Shoulder joint metal/polymer/metal | |
| nonconstrained or semi-constrained porous-coated | |
| uncemented prosthesis. | |
| Class: | II |
| Product Code: | MBF, PHX, KWS, KWT |
| Predicate Devices: | Primary Predicate: |
| SMR Anatomic Shoulder System, LimaCorporate S.p.A | |
| K162397 |
5
Indications for Use:
The SMR Shoulder System is intended for partial or total, primary or revision shoulder ioint replacement.
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; in case of SMR Short Stems only if sufficient bone ● stock remains);
- cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid 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 SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
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 stem, 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, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | • | SMR Short Stems (Cementless Finned) | Ti6Al4V | X |
6
| System | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not | ||
| Cem | |||||
| ● | 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 TT Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
| ● | ● | SMR TT Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | X | |
| ● | ● | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Baseplate | Ti6Al4V | X* | X* |
| ● | ● | SMR TT Augmented 360 Baseplate | Ti6Al4V | X | |
| ● | ● | SMR TT Glenoid 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) - Ta (ISO13782 - ASTM F560) |
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.
- SMR Lateralized Connectors are not indicated for use with glenoid bone grafting ● techniques.
- In the US the SMR TT Metal Back Baseplate 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.
- If a SMR TT Hybrid Glenoid is in place and revision to a reverse prosthesis is ● required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR TT Hybrid Glenoid Reverse Baseplate. The SMR TT Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
7
- The Dia. 50, 52 and 54mm Humeral Heads with + 3mm increased height cannot be be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
Device Description:
The SMR Shoulder System is a shoulder system. The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are glenoid components intended to be used in combination with the previously cleared components of the SMR Shoulder System (humeral stems, humeral bodies, adaptor tapers, humeral heads) to achieve an anatomic configuration.
The purpose of the Special 510(k) is to add an alternative sterilization method for SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid.
The SMR TT Hybrid Glenoid is composed by a poly baseplate and a peg. The poly baseplate is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648) and Tantalum (ISO 13782 ASTM F560). The peg is manufactured from Ti6Al4V (ISO 5832-3 ASTM F1472).
The SMR 3-Pegs Cemented Glenoid is manufactured from conventional (non-crosslinked) UHMWPE (ISO 5834-2 ASTM F648).
The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid can be sterilized using a minimum gamma radiation dose of 25 kGy.
Substantial Equivalence:
The SMR TT Hybrid Glenoid and SMR 3-Pegs Cemented Glenoid are substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance.
Preclinical Testing:
The following activities were performed:
- Sterilization validation
- Packaging validation ●
- UHMWPE Characterization
Clinical Testing:
Clinical testing was not necessary to support substantial equivalence.
Conclusion:
The SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid possesses the same intended use and similar technological characteristics as the predicate devices. Therefore, the SMR TT Hybrid Glenoid and the SMR 3-Pegs Cemented Glenoid are substantially equivalent to the respective predicate device identified in this premarket notification.