(161 days)
No
The document describes a mechanical shoulder implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a total shoulder replacement system, which clearly falls under the definition of a therapeutic device as it is used to treat and alleviate symptoms associated with various shoulder conditions by replacing damaged joints.
No
Explanation: The SMR Shoulder System is an implant intended for joint replacement, not for diagnosing conditions. Its primary function is therapeutic, replacing diseased or damaged shoulder joints.
No
The device description explicitly states it is manufactured from Ti6Al4V alloy and describes physical components like humeral bodies, stems, and liners, indicating it 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 procedure performed on a patient's body.
- Device Description: The device description details the materials and components of a shoulder implant, which is an orthopedic device.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is an implant used in vivo (inside the body) for surgical replacement.
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 patients 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 are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid 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.
Product codes
MBF, PHX, KWS, KWT, HSD
Device Description
The SMR 140° Reverse Humeral Bodies (SMR 140° Reverse Humeral Body, SMR 140° Short Reverse Humeral Body, SMR 140° Finned Reverse Humeral Body) are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3); they are for taper-coupling with previously cleared Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / humeral head
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 identified through FE analysis:
- fatigue-fretting behaviour of the new SMR 140° Reverse Humeral Bodies;
- evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K100858, K101263, K110598, K111212, K113254, K133349, K113523, K142139, K163397, K172456, K191746, K051075, K092873, K112069, K141006
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
December 17, 2020
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: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.
LimaCorporate S.p.A. % Lacey Harbour US Regulatory Manager Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington. Texas 76006 USA
Re: K201905
Trade/Device Name: SMR 140° Reverse Humeral Body Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, PHX, KWS, KWT, HSD Dated: November 13, 2020 Received: November 16, 2020
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.
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
1
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,
Michael Owens 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number K201905
Device Name
SMR 140° Reverse Humeral Body
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 coff deficient joint with severe arthropathy (disabled shoulder). The patients 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 are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid 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 Short Stems (Cementless Finned) | 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 |
3
| ● | • * | SMR TT Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
|---|---|---|---|---|---|
| ● | • | SMR TT Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | X | |
| ● | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| ● | • | SMR TT Baseplate | Ti6Al4V | X* | X* |
| ● | • | SMR TT Augmented 360 Baseplate | Ti6Al4V | X | |
| ● | • | SMR TT Glenoid 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
*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 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 tannot 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
510(k) Summary
Date: June 30, 2020
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 140° Reverse | ||
| Humeral Body | ||
| (included in SMR | ||
| Shoulder System) | MBF | Prosthesis, Shoulder, Semi-Constrained, |
| Metal/Polymer, Uncemented per 21 CFR | ||
| 888.3670 | ||
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic | |
| Uncemented per 21 CFR 888.3690 | ||
| 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 |
Description:
The SMR 140° Reverse Humeral Bodies (SMR 140° Reverse Humeral Body, SMR 140° Short Reverse Humeral Body, SMR 140° Finned Reverse Humeral Body) are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3); they are for tapercoupling with previously cleared Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963).
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):
Traditional 510(k) - SMR 140° Reverse Humeral Body June 30th, 2020
5
- . cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to . Walch classification (SMR TT Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral 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 of a a metal back/connector/glenosphere consists or of 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 Short Stems (Cementless | |||
| Finned) | 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, | Ti6Al4V | X | X |
6
| Eccentric) | ||||||
|---|---|---|---|---|---|---|
| ● | 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 TT Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X | |
| SMR TT Hybrid Glenoid Reverse | ||||||
| Baseplate + Screw | Ti6Al4V | X | ||||
| ● | ● | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* | |
| ● | ● | SMR TT Baseplate | Ti6Al4V | X* | X* | |
| ● | SMR TT Augmented 360 | |||||
| Baseplate | Ti6Al4V | X | ||||
| ● | ● | SMR TT Glenoid 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
*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 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.
7
- 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 | SMR Shoulder | |
| System including | |||
| SMR Reverse | |||
| Humeral Body | Main reference: K191963 | ||
| Other references: K100858, K101263, | |||
| K110598, K111212, K113254, | |||
| K133349, K113523, K142139, | |||
| K163397, K172456, K191746. | |||
| 2 | DJO SURGICAL | ||
| (LEGALLY ENCORE | |||
| MEDICAL, L.P.) | RSP Reverse | ||
| Shoulder | |||
| Prosthesis | K041066, K051075, K092873, | ||
| K112069, K141006. |
Summary of technology comparison:
The intended use, design, and materials of the SMR 140° Reverse Humeral Bodies are substantially equivalent to the ones of the predicate devices. Design Control Activities have been successfully completed.
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 identified through FE analysis:
- fatigue-fretting behaviour of the new SMR 140° Reverse Humeral Bodies; .
- evaluation of residual torque of the safety screw and push-out force of the coupling . between stem and humeral body.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR 140° Reverse Humeral Bodies to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the SMR 140° Reverse Humeral Bodies are substantially equivalent to the predicate devices identified in this premarket notification.