(247 days)
Not Found
No
The summary describes a modular shoulder implant system and its manufacturing process, with no mention of AI or ML technology.
Yes
The device is a system for joint replacement, specifically in the shoulder, which is a therapeutic intervention aimed at treating medical conditions like degenerative joint disease, fractures, and failed implants.
No
Explanation: This device is a shoulder joint replacement system, which is a prosthetic implant used for treatment of joint conditions, not for diagnosis.
No
The device description clearly details physical components made of polyethylene and titanium, intended for surgical implantation. This is a hardware medical device.
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 is a surgical implant used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details the components of the shoulder system, such as glenoid components, baseplates, pegs, and glenospheres. These are all physical implants designed to be surgically placed in the shoulder.
- 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 in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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. 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 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 of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal back determines if the construct is cemented or uncemented.
Product codes (comma separated list FDA assigned to the subject device)
MBF, KWT, KWS, PHX, PAO
Device Description
The SMR Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.
The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.
If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.
This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.
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 was conducted based on the following standards:
- ASTM E8: Tensile test: .
- ASTM F1044: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and . Metallic Coatings;
- ASTM F1147: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings;
- . ASTM F1160: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings;
- . ASTM F1978: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser;
- . Fatigue Fretting test on Hybrid glenoid used in reverse.
Clinical testing was not necessary to demonstrate substantial equivalence.
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.
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
§ 888.3670 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
December 21, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes 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: K231099
Trade/Device Name: SMR Hybrid Glenoid 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, KWT, KWS, PHX, PAO Dated: October 23, 2023 Received: November 17, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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. Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2023.12.21 08:27:50 -05'00"
for: Farzana Sharmin, PhD 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
2
Enclosure
3
Indications for Use
510(k) Number
Device Name
SMR Hybrid Glenoid 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 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. 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 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 of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal back determines if the construct is cemented or uncemented.
4
| 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 | ||
| 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 |
A= Anatomic / R=Reverse
(ISO13782 - ASTM F560)
*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 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).
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
5
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6
510(k) Summary
Date: 19-December-2023 Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Kenneth Newman Regulatory Affairs Associate Email: kenneth.newman(@)limacorporate.com Phone: 682-597-3381 FAX: +39 0432945512
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| 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 | ||
| SMR Hybrid Glenoid System | MBF | Shoulder joint metal/polymer/metal |
| nonconstrained or semi-constrained porous-coated | ||
| uncemented prosthesis per 21 CFR 888.3670 | ||
| PAO | Shoulder joint metal/polymer semi-constrained | |
| cemented prosthesis per 21 CFR 888.3660 | ||
| PHX | Shoulder joint metal/polymer semi-constrained | |
| cemented prosthesis per 21 CFR 888.3660 |
Description:
The SMR Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.
The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.
If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.
This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.
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;
7
- 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 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 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.
| 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 |
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.
8
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| ● | 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 (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 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).
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |||||||
|---|---|---|---|---|---|---|---|
| No. | Company | Device name | Cleared via | ||||
| (Primary Predicate) LimaCorporate S.p.A SMR Hybrid Glenoid System | K223876 | ||||||
| Exactech, Inc. | Exactech® Equinoxe® Laser Cage Glenoid K212356 |
Predicate Devices:
9
Summary of technology comparison:
The intended use, design, and materials of the SMR Hybrid Glenoid System with SLM manufactured central TT peg is identical to the ones of the Hybrid Glenoid System (K223876).
Non-clinical testing
Performance testing of SMR Hybrid Glenoid System with SLM manufactured central TT peg was conducted according to the following test standards:
- ASTM E8: Tensile test: .
- ASTM F1044: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and . Metallic Coatings;
- ASTM F1147: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings;
- . ASTM F1160: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings;
- . ASTM F1978: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser;
- . Fatigue Fretting test on Hybrid glenoid used in reverse.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of SMR Hybrid Glenoid System with SLM manufactured central TT peg to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Hybrid TT peg made from SLM manufacturing is substantially equivalent to the predicate device.