(42 days)
No
The document describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for shoulder joint replacement to treat various degenerative joint diseases, fractures, and failed implants, which directly addresses medical conditions to restore function or improve health.
No
Explanation: The SMR Shoulder System is described as a system for shoulder joint replacement (a prosthetic device), not a device used to diagnose a medical condition.
No
The device description clearly states it is a "complete system intended to be used in primary or revision total shoulder joint replacement" and lists various hardware components like "humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs." This indicates it is a physical implant system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SMR Shoulder System is for "partial or total, primary or revision shoulder joint replacement." This describes a surgical implant used within the body to replace a joint.
- Device Description: The device description details components like humeral stems, reverse humeral bodies, liners, glenospheres, and glenoid components. These are all physical components designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is an implant used inside the body.
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 ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary 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 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.
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 of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
Product codes
MBF, PHX, KWS, KWT, PAO
Device Description
The SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792.
The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration 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 Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws.
Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs.
With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced:
- Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349);
- -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).
No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.
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)
Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices. Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028) was performed on worst case components.
Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K212800, K210717, K113254, K133349, K163397, K212800
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
February 3, 2023
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
LimaCorporate S.p.A. % Kenneth Newman Regulatory Affairs Associate Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, Texas 76006
Re: K223876
Trade/Device Name: SMR Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, PHX, KWS, KWT, PAO Dated: December 22, 2022 Received: December 23, 2022
Dear Kenneth Newman:
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.
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.02.03
16:35:46 -05'00'
For Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
K223876
Device Name
SMR Shoulder System
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 ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary 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 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.
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 of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
| System | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not | ||
| Cem | |||||
| ● | ● | SMR Stem (Cemented, Cemented Revision) | Ti6Al4V | X | |
| ● | ● | SMR Stem (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| ● | ● | SMR Short Stem (Cementless Finned) | Ti6Al4V | X | |
| ● | ● | SMR Humeral Body (Trauma, Finned) | Ti6Al4V | X | X |
| ● | ● | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| ● | ● | Humeral Extension | Ti6Al4V | X | X |
| ● | ● | SMR Humeral Head (Standard*, CTA) | CoCrMo | X | X |
| ● | ● | SMR Adaptor Taper (Neutral, Eccentric) | Ti6Al4V | X | X |
| ● | ● | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| ● | SMR Glenosphere* | CoCrMo | X | ||
| ● | SMR Connector* | Ti6Al4V | X |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
| UHMWPE | X | X | |||
|---|---|---|---|---|---|
| ● | Reverse Liner | LimaVit™ (Vitamin E | |||
| highly crosslinked | |||||
| UHMWPE) | X | X | |||
| ● | SMR Cemented Glenoid | UHMWPE | X | ||
| ● | SMR 3 Pegs Cemented Glenoid | UHMWPE | X | ||
| ● | * | SMR TT Hybrid Glenoid | UHMWPE+ Ti6Al4V 3D | ||
| printed +Ta | X | X | |||
| ● | SMR TT Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | X | ||
| ● | ● | SMR Metal Back Glenoid | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Baseplate | Ti6Al4V | X* | X* |
| ● | SMR TT Augmented 360 Baseplate | Ti6Al4V | X | ||
| ● | ● | SMR TT Glenoid Peg | Ti6Al4V 3D printed | X | X |
| ● | SMR Metal Back Liner | UHMWPE | X* | X* | |
| * | ● | SMR Bone screw | Ti6Al4V | X | |
| Material Standards | |||||
| Ti6Al4V (ISO 5832-3 - ASTM F1472) – Ti6Al4V 3D printed (to meet the mechanical and chemical requirements of ISO 5832-3) - | |||||
| CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - LimaVit™ (Vitamin E highly crosslinked | |||||
| UHMWPE) (ISO 5834-2 - ASTM F648 - ASTM F2695 – ASTM F2565) - PoroTi Titanium Coating (ASTM F1580) - Ta | |||||
| (ISO12782 - ASTM F560) |
A= Anatomic / R=Reverse
*NOTE:
- When considering the humeral side, SMR Glenosphere 042 can be coupled only with PRIMA Humeral System.
- 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 Baseplateused 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.
- The Dia. 50. 52 and 54mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor . Tapers (both concentricand eccentric). The Dia. 52 and 54mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Date: January 31st, 2023
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Kenneth Newman Kenneth.Newman@limacorporate.c om Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682-597-3381
Trade name: SMR Shoulder System Common name: Glenoid Shoulder Prosthesis
| Classification Name: | |
|---|---|
| Product Code | Regulation and Classification Name |
| MBF | § 888.3670 - Shoulder joint metal/polymer/metal nonconstrained or |
| semi-constrained porous-coated uncemented prosthesis. | |
| PHX | § 888.3660 - Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis. | |
| KWS | § 888.3660 - Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis. | |
| KWT | § 888.3650 - Shoulder joint metal/polymer non-constrained |
| cemented prosthesis. | |
| PAO | § 888.3660 - Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis. |
Classification Name:
Description:
The SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792.
The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration 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 Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws.
5
Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs.
With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced:
- Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349);
- -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).
No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.
Intended Use:
Indications
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 revisionshoulder jointreplacement 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 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, a polyethylene glenoid with metalpeg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/comnector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
6
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| ● | ● | SMR Stem (Cemented, Cemented Revision) | Ti6Al4V | X | |
| ● | ● | SMR Stem (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| ● | ● | SMR Short Stem (Cementless Finned) | Ti6Al4V | X | |
| ● | SMR Humeral Body (Trauma, Finned) | Ti6Al4V | X | X | |
| ● | ● | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| ● | ● | Humeral Extension | Ti6Al4V | X | X |
| ● | SMR Humeral Head (Standard*, CTA) | CoCrMo | X | X | |
| ● | SMR Adaptor Taper (Neutral, Eccentric) | Ti6Al4V | X | X | |
| ● | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X | |
| ● | SMR Glenosphere* | CoCrMo | X | ||
| ● | SMR Connector* | Ti6Al4V | X | ||
| UHMWPE | X | X | |||
| ● | Reverse Liner | LimaVit™ (Vitamin | |||
| E highly crosslinked | |||||
| UHMWPE) | X | X | |||
| ● | SMR Cemented Glenoid | UHMWPE | X | ||
| ● | SMR 3 Pegs Cemented Glenoid | UHMWPE | X | ||
| ● | ● * | SMR TT Hybrid Glenoid | UHMWPE+ Ti6Al4V | ||
| 3D printed +Ta | X | X | |||
| ● | SMR TT Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | X | ||
| ● | ● | SMR Metal Back Glenoid | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Baseplate | Ti6Al4V | X* | X* |
| ● | SMR TT Augmented 360 Baseplate | Ti6Al4V | X | ||
| ● | ● | SMR TT Glenoid Peg | Ti6Al4V 3D printed | X | X |
| ● | SMR Metal Back Liner | UHMWPE | X* | X* | |
| ● * | ● | SMR Bone screw | Ti6Al4V | X |
Ti6Al4V (ISO 5832-3 - ASTM F1472) – Ti6A14V 3D printed (to meet the mechanical and chemical requirements of ISO 5832-3) - CoCrMo (ISO 5832-12 - ASTM F1537) - UHMWPE (ISO 5834-2 - ASTM F648) - Lima Vit'M (Vitamin E highly crosslinked UHMWPE) (ISO 5834-2 - ASTM F648 - ASTM F2695 – ASTM F2565) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)
A= Anatomic / R=Reverse
*NOTE:
- When considering the humeral side, SMR Glenosphere Ø42 can be coupled only with PRIMA ● Humeral System.
- 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
7
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.
- . 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).
Predicate Devices:
The predicate device is the SMR Shoulder System cleared by LimaCorporate via K220792.
Summary of technology comparison:
The subject device has the exact same principles of operation, materials, and performance characteristics of the predicate SMR Shoulder System cleared via K220792.
The only differences between the subject and the predicate device are the addition of new compatibilities between already cleared devices:
- Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back -Glenoid (K113254) and SMR TT Baseplate (K133349)
- -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).
The indications for use of the subject SMR Shoulder System are the same as the predicate SMR Shoulder System.
Non-clinical testing
Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices. Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028) was performed on worst case components.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device.
Conclusions
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, SMR Shoulder System with new compatibilities is substantially equivalent to the predicate device identified in this premarket notification.