(56 days)
No
The summary describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
This device is a total shoulder replacement system indicated for patients with a severely arthropathic shoulder, aiming to alleviate symptoms and restore function, which classifies it as a therapeutic device.
No
This device is described as a modular shoulder system intended for total shoulder replacement, specifically components like glenoid baseplates, spheres, and screws. Its purpose is to be implanted in the body to treat severe arthropathy, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like Ti6Al4V, CoCrMo, and UHMWPE, indicating it is a hardware-based medical device (a shoulder replacement system).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The PRIMA Glenoid System is a surgical implant designed to replace components of the shoulder joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for total shoulder replacement surgery in patients with specific shoulder conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a medical device used in surgery, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.
Product codes
MBF, PHX
Device Description
The PRIMA TT Glenoid, that is part of the PRIMA Glenoid System, is a modular shoulder system intended to be used in combination with the previously cleared humeral components of the SMR Shoulder System (K220792) and PRIMA Humeral System (K212800).
The new system components include a monoblock glenoid baseplate, a modular glenoid baseplate and the related glenoid peg, a glenosphere connector with screw, central and peripheral bone screws and locking caps.
The baseplates are provided in different angulations, ranging between 10° and 20°, and in different offsets, up to +4mm lateralization. The glenosphere has articular diameter 36, 40 and 42mm and the connector with screw is available in low, medium and high lateralization. Central compressive screws are available in dia. 5 and 6.5mm and in length ranging between 25 and 50mm, while peripheral screws are available in dia. 5mm and in length ranging between 18 to 50mm.
Baseplates, peg, screws and locking cap are made of Ti6Al4V, the glenosphere is made of CoCrMo and the glenosphere connector with screw is made of Ti6Al4V and UHMWPE.
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 (Part 21 CFR 801 Subpart D)
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 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, including: Evaluation of modular connection dissociation strength, Fatigue fretting test on glenoid baseplates in reverse shoulder configuration, Evaluation of modular connection dissociation strength post-fatigue, Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028), and Evaluation of range of motion for worst case devices.
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA TT Glenoid to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.”
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October 6, 2022
Image /page/0/Picture/1 description: The image shows 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 blue, and the word "ADMINISTRATION" in a smaller font below that.
LimaCorporate S.p.A. % Kenneth Newman Official Correspondent Lima USA Inc. 2001 NE Green Oaks Blvd. Ste 100 Arlington, Texas 76006
Re: K222427
Trade/Device Name: PRIMA TT Glenoid 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 Dated: August 8, 2022 Received: August 11, 2022
Dear Kenneth Newman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Victoria Lilling, M.D. 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222427
Device Name
PRIMA TT Glenoid
Indications for Use (Describe)
The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
Date: October 06, 2022
Manufacturer: LimaCorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Kenneth Newman Kenneth.Newman@limacorporate.com Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682-597-3381
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| PRIMA TT Glenoid | MBF | 21 CFR 888.3670 – Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis |
| PHX | 21 CFR 888.3660 – Shoulder joint metal/polymer semi-constrained cemented prosthesis |
Description
The PRIMA TT Glenoid, that is part of the PRIMA Glenoid System, is a modular shoulder system intended to be used in combination with the previously cleared humeral components of the SMR Shoulder System (K220792) and PRIMA Humeral System (K212800).
The new system components include a monoblock glenoid baseplate, a modular glenoid baseplate and the related glenoid peg, a glenosphere connector with screw, central and peripheral bone screws and locking caps.
The baseplates are provided in different angulations, ranging between 10° and 20°, and in different offsets, up to +4mm lateralization. The glenosphere has articular diameter 36, 40 and 42mm and the connector with screw is available in low, medium and high lateralization. Central compressive screws are available in dia. 5 and 6.5mm and in length ranging between 25 and 50mm, while peripheral screws are available in dia. 5mm and in length ranging between 18 to 50mm.
Baseplates, peg, screws and locking cap are made of Ti6Al4V, the glenosphere is made of CoCrMo and the glenosphere connector with screw is made of Ti6Al4V and UHMWPE.
Indications for Use
The PRIMA Glenoid 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.
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The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.
| No. | Company | Device name | Cleared via |
|---|---|---|---|
| 1 | |||
| (Primary Predicate) | LimaCorporate S.p.A | SMR Reverse Liner | K220792 |
| 2 | Tornier, Inc. | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | K161742 |
Predicate Devices:
Summary of technology comparison
PRIMA TT Glenoid and SMR Shoulder System including SMR TT Augmented 360 Glenoid (primary predicate) have extensive and significant similarities in terms of intended use, indications, technological characteristics, materials, and principles of operation. The main differences between these two systems relates to the presence of porous surface on the backside of the baseplates and the use of the central compressive screw, features that are not available for the predicate device. To establish a proper and complete substantial equivalence discussion of the subject device with marketed predicate devices, the Aequalis PerFORM & Aequalis PerFORM+ Reversed Glenoids is also included as predicate devices for PRIMA TT Glenoid. The predicate Aequalis PerFORM & Aequalis PerFORM+ Reversed Glenoids features a porous surface on the backside of the baseplates and the use of the central compressive screw.
A comparison of technological characteristics and performance testing demonstrate that the PRIMA TT Glenoid is substantially equivalent to 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:
- Evaluation of modular connection dissociation strength
- Fatigue fretting test on glenoid baseplates in reverse shoulder configuration ●
- Evaluation of modular connection dissociation strength post-fatigue
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028) ●
- . Evaluation of range of motion for worst case devices
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA TT Glenoid to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, PRIMA TT Glenoid is substantially equivalent to the predicate devices identified in this premarket notification.