(84 days)
No
The document describes a mechanical shoulder implant system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a shoulder replacement system intended to treat conditions like degenerative joint disease, fractures, and failed implants, which indicates its use in treating or alleviating a disease or injury.
No
The device is a shoulder joint replacement system, which is a therapeutic device used for treatment, not diagnosis. The "Intended Use / Indications for Use" describes conditions for which the device is used for treatment, such as "shoulder joint replacement," "treatment of acute fractures," and "revision of a failed primary implant."
No
The device description explicitly details physical components made of Ti6Al4V alloy and describes mechanical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "partial or total, primary or revision shoulder joint replacement." This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as a "Shoulder System" with components like "Connectors" made from Ti6Al4V alloy. These are physical implants designed to replace or augment a joint.
- Anatomical Site: The anatomical site is the "Shoulder joint," which is within the human body.
- Performance Studies: The performance studies mentioned are "Mechanical tests" evaluating aspects like "glenoid loosening and dissociation," "Fatigue-fretting behaviour," and "corrosion." These are tests related to the physical properties and durability of the implant.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not fit that description. It is an implantable medical device used in a surgical procedure.
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;
- cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR 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 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 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 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 of a peg/ baseplate/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 (comma separated list FDA assigned to the subject device)
KWS, KWT, MBF, PHX
Device Description
The SMR Connectors are used to couple the glenosphere to the metal-backed glenoid. Connectors are made from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a double male taper. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. No.5 additional sizes (Lateralized connectors) are available in both Small-STD and Small-R configuration to allow lateralization of Center of Rotation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: Mechanical tests (Dynamic evaluation of glenoid loosening and dissociation per ASTM F2028-18, Fatigue-fretting behaviour and endurance stability of the taper connection followed by evaluation for corrosion) demonstrated device performances fulfill the intended use and are substantially equivalent to the predicate devices. Mechanical testing was performed on worst case components or constructs.
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Connectors 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.
K100858, K101263, K110598, K111212, K113254, K133349, K142139, K163397, K172456
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.
K092873, K112069, K041066, K051075, K141006, K161742
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font, and the word "ADMINISTRATION" in a smaller, regular blue font.
January 25, 2019
Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K183042
Trade/Device Name: SMR Lateralized Connectors with screws 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: October 22, 2018 Received: November 2, 2018
Dear Stephen Peoples:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi - S Digitally signed by V
For:Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183042
Device Name
SMR Lateralized connectors with screws
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 replace ment in patients suffering from disability due to:
- · non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · inflammatory degenerative joint disease such as rheumatoid arthritis;
- " treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- · revision of a failed primary implant;
- · cuff tear arthropathy (CTA Heads only);
· glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR 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 joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is neces-sary to use the device. The 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 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 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 of a peg/ baseplate/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 | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not | ||
| Cem | |||||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | Humeral Extension | Ti6Al4V | X | X |
| • | SMR Humeral Heads (Standard*, CTA) | CoCrMo | X | X | |
| • | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X | |
| • | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
3
| • | SMR Glenospheres | CoCrMo | X | ||
|---|---|---|---|---|---|
| • | SMR Connectors* | Ti6Al4V | X | ||
| • | Reverse Liners | UHMWPE | X | ||
| • | SMR Cemented Glenoids | UHMWPE | X | ||
| • | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | ||
| • | * | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | |
| • | SMR 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 Metal Back Peg | Ti6Al4V | X | X | |
| • | SMR Metal Back Liner | UHMWPE | X* | X | |
| • | * | SMR Bone screws | Ti6Al4V | X |
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 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 Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
· The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
· The Dia. 52 and 54 mm 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K183042
Summary of Safety and Effectiveness
Date: January 18, 2018
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant SPeoplesVMD@gmail.com PEOPLES & ASSOCIATES CONSULTING, ITC 411 Auditorium Blvd. Winona Lake, IN 46590 Phone: 260-645-0327 FAX: +39 0432945512
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| SMR Lateralized | ||
| connectors with screws | ||
| (included in SMR | ||
| Reverse Shoulder | ||
| System) | 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 | ||
| MBF | Prosthesis, Shoulder, Semi-Constrained, | |
| Metal/Polymer, Uncemented per 21 CFR | ||
| 888.3670 | ||
| PHX | Shoulder Prosthesis, Reverse Configuration | |
| per 21 CFR 888.3660 |
Description:
The SMR Connectors are used to couple the glenosphere to the metal-backed glenoid. Connectors are made from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a double male taper. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. No.5 additional sizes (Lateralized connectors) are available in both Small-STD and Small-R configuration to allow lateralization of Center of Rotation.
Intended 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;
Traditional 510(k) – SMR Lateralized Connectors with screws January 18, 2018
Company Confidential Page 1 of 4
5
K183042
- o cuff tear arthropathy (CTA Heads only);
- . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR 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 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 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 back/connector/glenosphere 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 | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not | ||
| Cem | |||||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | Humeral Extension | Ti6Al4V | X | X |
| • | • | SMR Humeral Heads (Standard*, CTA) | CoCrMo | X | X |
| • | • | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| • | • | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | SMR Glenospheres | CoCrMo | X | |
| • | • | SMR Connectors* | Ti6Al4V | X | |
| • | • | Reverse Liners | UHMWPE | X | X |
| • | SMR Cemented Glenoids | UHMWPE | X | ||
| • | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | ||
| • | • * | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V | ||
| +Ta | X | X |
Traditional 510(k) - SMR Lateralized Connectors with screws January 18, 2018
Company Confidential Page 2 of 4
6
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| ● | SMR 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 Metal Back Peg | Ti6Al4V | X | X |
| ● | ● | SMR Metal Back Liner | UHMWPE | X* | X* |
| ● * | ● | SMR Bone screws | Ti6Al4V | X | |
| Material Standards | |||||
| Ti6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - | |||||
| ASTM F648) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560) |
A= Anatomic / R=Reverse
*NOTES:
- 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 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 Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
- . The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
| Company | Device name | Cleared via |
|---|---|---|
| Limacorporate | SMR Reverse Shoulder System | K100858, K101263, |
| K110598, K111212, | ||
| K113254, K133349, | ||
| K142139, K163397, | ||
| K172456 | ||
| DJO Surgical (legally | ||
| Encore Medical, L.P.) | RSP Reverse Shoulder Prosthesis | K092873, K112069, |
| K041066, K051075, | ||
| K141006 | ||
| Tornier | Aequalis PerFORM Reversed & | |
| Aequalis PerFORM+ Reversed Glenoid | K161742 |
Predicate Devices:
Traditional 510(k) - SMR Lateralized Connectors with screws January 18, 2018
Company Confidential Page 3 of 4
7
K183042
Summary of technology comparison:
The intended use, design (fixation, taper couplings, offset) and materials of the SMR Lateralized Connectors with screws are substantially equivalent to the ones of the predicate devices. Design Control Activities have been successfully completed.
Non-clinical testing
Mechanical tests (Dynamic evaluation of glenoid loosening and dissociation per ASTM F2028-18, Fatigue-fretting behaviour and endurance stability of the taper connection followed by evaluation for corrosion) demonstrated device performances fulfill the intended use and are substantially equivalent to the predicate devices. Mechanical testing was performed on worst case components or constructs.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Connectors to the predicate devices.