(62 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 a shoulder joint replacement system, which aims to alleviate symptoms, restore function, and treat diseases like osteoarthritis, rheumatoid arthritis, and fractures.
No
Explanation: The provided text describes the SMR Shoulder System as an implant for partial or total shoulder joint replacement. Its intended use is to replace diseased or damaged joints, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is made from physical materials (LimaVit) and is intended for surgical implantation as a shoulder joint replacement component. This indicates it is a physical medical device, not software-only.
Based on the provided information, 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 implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
IVD devices are used outside the body to examine specimens and provide diagnostic information. This device is implanted within the body to treat a physical condition.
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 if the construct is cemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal pack 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 (comma separated list FDA assigned to the subject device)
MBF, PHX, KWS, KWT, PAO
Device Description
SMR Reverse Liners are made from LimaVit (cross-linked ultra-high molecular weight polyethylene with Vitamin E) conforming to ISO 5834-2, ASTM F648 and ASTM F2695. SMR Reverse Liners are coupled to SMR Reverse Humeral Bodies (K110598, K201905), with or without the use of the SMR Humeral Extension (K113523), and articulates with the SMR Glenosphere (K110598, K142139, K163397). SMR Reverse Liners have an articulating surface diameter of 36 mm and 40mm to articulate with the same diameter glenospheres respectively.
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.
Mechanical testing was performed on worst case components or constructs:
- Fatigue test
- Wear test
- Pull-out, torque-out and lever-out test.
Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR Reverse Liners 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.
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.
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
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 19, 2022
LimaCorporate S.p.A. % Lacey Harbour Regulatory, Quality & Clinical Sr.Manager Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006
Re: K220792
Trade/Device Name: SMR Reverse Liner Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder Joint Metal/Polymer/Metal Nonconstrained Or Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBF, PHX, KWS, KWT, PAO Dated: March 10, 2022 Received: March 18, 2022
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 Quality 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)
Device Name
SMR Reverse Liner
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 if the construct is cemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal pack 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 | 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 |
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 |
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 GlenoidLiner 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).
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
Date: May 19, 2022
Manufacturer: LimaCorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Lacey Harbour lacey.harbour@limacorporate.com Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| SMR Reverse Liner | ||
| (included in SMR | ||
| Shoulder System) | MBF | Shoulder joint metal/polymer/metal |
| nonconstrained or semi-constrained porous- | ||
| coated uncemented prosthesis per 21 CFR | ||
| 888.3670 | ||
| PHX | Shoulder Prosthesis, Reverse Configuration per | |
| 21 CFR 888.3660 | ||
| KWS | Prosthesis, Shoulder, Semi-Constrained, | |
| Metal/Polymer Cemented per 21 CFR 888.3660 | ||
| KWT | Prosthesis, Shoulder, Non-Constrained, | |
| Metal/Polymer Cemented per 21 CFR 888.3650 | ||
| PAO | Prosthesis, Shoulder, Semi-Constrained, | |
| Metal/Polymer + Additive, Cemented per 21 | ||
| CFR 888.3660 |
Description:
SMR Reverse Liners are made from LimaVit (cross-linked ultra-high molecular weight polyethylene with Vitamin E) conforming to ISO 5834-2, ASTM F648 and ASTM F2695. SMR Reverse Liners are coupled to SMR Reverse Humeral Bodies (K110598, K201905), with or without the use of the SMR Humeral Extension (K113523), and articulates with the SMR Glenosphere (K110598, K142139, K163397). SMR Reverse Liners have an articulating surface diameter of 36 mm and 40mm to articulate with the same diameter glenospheres respectively.
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 ●
5
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.
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.
| 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 | ||
| ● | 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 |
6
| • | • | 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 |
Material Standards
Ti6A14V (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) - 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).
Predicate Devices:
| No. | Company | Device name | Cleared via |
|---|---|---|---|
| 1 (Primary Predicate) | LIMACORPORATE | Physica KR Liner and SMR | |
| Reverse Humeral Liner | K190911 | ||
| 2 (Additional Predicate) | LIMACORPORATE | Bone Screws dia. 5,0 mm | K210717 |
Reference Devices:
| No. | Company | Device name | Cleared via |
|---|---|---|---|
| 1 | LIMACORPORATE | Delta TT Pro | K182099 |
7
Summary of technology comparison:
The intended use, design, and materials of the SMR Reverse Liners are substantially equivalent to the ones of the predicate devices.
Non-clinical testing:
Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices.
Mechanical testing was performed on worst case components or constructs:
- Fatigue test ●
- Wear test
- Pull-out, torque-out and lever-out test .
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR Reverse Liners to the predicate devices.
Conclusion:
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the SMR Reverse Liners are substantially equivalent to the predicate devices identified in this premarket notification.