(206 days)
Not Found
No
The document describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a system for partial or total shoulder joint replacement, intended to treat conditions like degenerative joint disease, fractures, or revision of failed implants, which clearly indicates a therapeutic purpose.
No
Explanation: This device is a shoulder implant system intended for replacement of shoulder joints. Its purpose is therapeutic (to treat a condition), not diagnostic (to identify or characterize a medical condition).
No
The device description clearly describes physical implants (glenoid component, reverse baseplate, screws, glenosphere, etc.) made of materials like polyethylene and Trabecular Titanium, intended for surgical implantation. This is a hardware medical device, 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 describes a surgical implant for replacing parts of the shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the shoulder replacement system (glenoid components, baseplates, screws, etc.). These are all physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition.
IVD devices are used in vitro (outside the body) to examine specimens for diagnostic purposes. This device is used in vivo (inside the body) as a replacement for damaged joint structures.
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 arthroplasty (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 stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists 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.
Product codes
MBF, PHX, KWS, KWT
Device Description
The SMR Hybrid Glenoid System is a modular shoulder system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a glenoid component (SMR Hybrid Glenoid) 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.
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
Prescription Use
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 testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Static Evaluation of the Glenoid Locking Mechanism in Shear (ASTM F1829);
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028);
- . Fatigue Fretting test on Glenoid Baseplate in reverse shoulder configuration;
- Range of motion (ASTM F1378). ●
LAL testing was performed to establish that the subject device meets pyrogen limit specification of 20EU/device.
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Hybrid Glenoid System 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.
K130642, K153722, K060694, K071090, K133349, K110598, K142139, K030710
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.
June 29, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K163397 Trade/Device Name: SMR Hybrid Glenoid System 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 Dated: May 29, 2017 Received: June 02, 2017
Dear Mr. 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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163397
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 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: A J , 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 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 hummeral 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 or 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 | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | 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 |
FORM FDA 3881 (8/14)
3
| 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 | |||
| • | 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 |
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.
· 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).
| Comments of the control of the control of the control consistence in the more of the comments of the comments of the manufactures were and
| 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
Summary of Safety and Effectiveness
Date: June 29, 2017
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 Phone: 260-645-0327 FAX: +39 0432945512
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| SMR Hybrid Glenoid System | 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 | ||
| MBF | Shoulder joint metal/polymer/metal | |
| nonconstrained or semi-constrained | ||
| porous-coated uncemented prosthesis per | ||
| 21 CFR 888.3670 | ||
| PHX | Shoulder joint metal/polymer semi- | |
| constrained cemented prosthesis per 21 | ||
| CFR 888.3660 |
Description:
The SMR Hybrid Glenoid System is a modular shoulder system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a glenoid component (SMR Hybrid Glenoid) 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
5
and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.
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; .
- Cuff tear arthroplasty (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 stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
| System | Use | ||||
|---|---|---|---|---|---|
| A | R | Components | Material | Cem | Not |
| Cem | |||||
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | X | |
| • | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
Traditional 510(k) – SMR Hybrid Glenoid System June 29, 2017
6
| System | Components | Material | Use | ||
|---|---|---|---|---|---|
| A | R | Cem | Not Cem | ||
| • | • | 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 |
| • | SMR Hybrid Glenoid 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 E1580) - Tantalum (ISO13782 - ASTM F560) |
A= Anatomic / R=Reverse
*NOTE :
- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- . The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- 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).
7
Predicate Devices:
- SMR 3-Pegs Glenoid, Limacorporate (K130642, K153722)
- Comprehensive Modular Hybrid Glenoid, Biomet Orthopedics, Inc. (K060694) ●
- Trabecular Metal Glenoid, Zimmer (K071090)
- SMR TT Metal Back, Limacorporate (K133349) ●
- SMR Glenospheres with connector and Screw. Limacorporate (K110598. ● K142139)
- Bio-Modular Shoulder System, Biomet Orthopedics, Inc. (K030710) .
Summary of technology comparison:
The intended use, design, and materials of the SMR Hybrid Glenoid System are substantially equivalent to the ones of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Non-clinical testing
Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Static Evaluation of the Glenoid Locking Mechanism in Shear (ASTM F1829);
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028);
- . Fatigue Fretting test on Glenoid Baseplate in reverse shoulder configuration;
- Range of motion (ASTM F1378). ●
LAL testing was performed to establish that the subject device meets pyrogen limit specification of 20EU/device.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Hybrid Glenoid System to the predicate devices.