(52 days)
Not Found
No
The document describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a shoulder joint replacement system intended to alleviate pain and disability caused by various shoulder conditions, which qualifies it as a therapeutic device.
No
The PRIMA Humeral System and PRIMA Glenoid System are implants for shoulder joint replacement surgery, not devices used for diagnosing medical conditions. The "Intended Use / Indications for Use" section clearly describes their purpose as replacement components for treating various shoulder joint pathologies.
No
The device description clearly outlines physical implants (humeral stems, glenoid screws) made of materials like Ti6A14V, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the PRIMA Humeral System and PRIMA Glenoid System are implants intended for surgical replacement of the shoulder joint. They are physical devices implanted into the body.
- Intended Use: The intended use describes the conditions for which the implants are used (e.g., osteoarthritis, fractures, rotator cuff tears) and the surgical procedures involved (partial or total shoulder replacement). This is a therapeutic use, not a diagnostic one.
The text focuses on the mechanical properties, materials, and surgical application of the implants, which are characteristic of a medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature 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 Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.
The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
- Avascular necrosis of the humeral head, ●
- . Traumatic/post-traumatic arthritis,
- Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
- . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
- . Cuff tear arthropathy (CTA Heads only).
The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.
The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:
- Rotator cuff tear arthropathy,
- Osteoarthritis with rotator cuff tear,
- Rheumatoid arthritis with rotator cuff tear,
- Massive irreparable rotator cuff tear,
- Avascular necrosis of the humeral head,
- Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
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, HSD, PAO, KWS, KWT
Device Description
This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.
The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.
The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.
The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.
The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.
As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, humeral head, glenohumeral joint, glenoid
Indicated Patient Age Range
Skeletally mature patients
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
Mechanical testing was performed on worst case components or constructs:
- Fatigue test of the humeral stem
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices.
Key Metrics
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.”
0
January 11, 2024
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, with the word "ADMINISTRATION" underneath.
LimaCorporate S.p.A % Kenneth Newman Senior Regulatory Affairs Specialist Lima U.S.A., Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, Texas 76006
Re: K233712
Trade/Device Name: PRIMA Humeral System; 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, HSD, PAO, KWS, KWT Dated: November 14, 2023 Received: November 20, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2024.01.11
17:42:36 -05'00'
Farzana Sharmin, PhD 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
510(k) Number (if known) K233712
Device Name
PRIMA Humeral System
Indications for Use (Describe)
The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature 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 Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.
The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
- Avascular necrosis of the humeral head, ●
- . Traumatic/post-traumatic arthritis,
- Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
- . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
- . Cuff tear arthropathy (CTA Heads only).
The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.
The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:
- Rotator cuff tear arthropathy,
- Osteoarthritis with rotator cuff tear,
- Rheumatoid arthritis with rotator cuff tear,
- Massive irreparable rotator cuff tear,
- Avascular necrosis of the humeral head,
- Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
3
-
Fractures of the humeral head where adequate fixation can be achieved and adequate bone ● stock remains.
The PRIMA Humeral System consists of the following single use components: -
Anatomic configuration: ●
- । stem
- adaptor for humeral heads. ।
-
Reverse configuration: ●
- stem -
- reverse tray
- reverse insert. -
| System | Components | Material | |||
|---|---|---|---|---|---|
| A | R | ||||
| ● | ● | PRIMA Short Stem | Ti6Al4V 3d printed | ||
| ● | ● | PRIMA Short Stem Plus | Ti6Al4V 3d printed | ||
| ● | ADAPTOR FOR HUMERAL HEADS | Ti6Al4V | |||
| ● | REVERSE TRAY | Ti6Al4V | |||
| ● | REVERSE INSERT | LimaVit™ (Vitamin E highly crosslinked | |||
| UHMWPE), Ti6Al4V | |||||
| Material Standards | |||||
| Ti6Al4V (ISO 5832-3 - ASTM F1472), Ti6Al4V 3d printed (ISO 5832-3), LimaVit™ (Vitamin E highly crosslinked UHMWPE) (ISO | |||||
| 5834-2 - ASTM F648 - ASTM F2695 - ASTM F2565) | |||||
| A = Anatomic, R = Reverse |
Table 1 PRIMA Humeral System components materials
The PRIMA Humeral System is intended to be used with all glenoids implants belonging to the SMR Shoulder System and PRIMA Glenoid System.
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
Submission Number (if known)
K233712
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
Date: January 02, 2024
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 Humeral | ||
| System | HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic |
| Uncemented per 21 CFR 888.3690 | ||
| PAO | Shoulder joint metal/polymer semi-constrained | |
| cemented prosthesis, per 21 CFR 888.3660 | ||
| 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 | ||
| PRIMA TT Glenoid | 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 |
Common name:
| Product | Common name |
|---|---|
| PRIMA Humeral System including | |
| PRIMA Short Stem Plus | Humeral shoulder prosthesis |
| PRIMA TT Glenoid including Central | |
| Compressive Cortical and Cancellous | |
| Screws L 20mm | Glenoid shoulder prosthesis |
Description:
This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.
The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the
6
stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.
The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.
The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.
The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.
As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).
Indications for Use:
PRIMA Humeral System
The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem Plus are intended for use in cemented applications, at the discretion of the surgeon.
The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis), ●
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis,
- Avascular necrosis of the humeral head.
- Traumatic/post-traumatic arthritis,
- Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains, ●
- Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate ● bone stock remains.
- . Cuff tear arthropathy (CTA Heads only).
The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.
The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:
- Rotator cuff tear arthropathy,
- Osteoarthritis with rotator cuff tear, ●
- Rheumatoid arthritis with rotator cuff tear, ●
- Massive irreparable rotator cuff tear, ●
- . Avascular necrosis of the humeral head,
7
- Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock . remains.
- Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains. ●
The PRIMA Humeral System consists of the following single use components:
- Anatomic configuration: ●
- stem
- adaptor for humeral heads. -
- Reverse configuration:
- stem -
●
- reverse tray
- reverse insert. -
| System | Components | Material | |
|---|---|---|---|
| A | R | ||
| • | • | PRIMA Short Stem | Ti6Al4V 3d printed |
| • | • | PRIMA Short Stem Plus | Ti6Al4V 3d printed |
| • | Adaptor for humeral heads | Ti6Al4V | |
| • | Reverse tray | Ti6Al4V | |
| • | Reverse insert | LimaVit™ (Vitamin E highly crosslinked UHMWPE), | |
| Ti6Al4V | |||
| Material Standards | |||
| Ti6Al4V (ISO 5832-3 - ASTM F1472), Ti6Al4V 3d printed (ISO 5832-3), LimaVit™ (Vitamin E highly crosslinked UHMWPE) (ISO | |||
| 5834-2 - ASTM F648 - ASTM F2695 - ASTM F2565) |
Table 1 PRIMA Humeral System components materials
The PRIMA Humeral System is intended to be used with all glenoids implants belonging to the SMR Shoulder System and PRIMA Glenoid System.
PRIMA TT Glenoid
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.
Predicate Devices:
| No. | Company | Device name | Cleared via |
|---|---|---|---|
| 1 (Primary Predicate) | LimaCorporate S.p.A | PRIMA TT Glenoid | K222427 |
| 2 | LimaCorporate S.p.A | PRIMA Humeral System | K212800 |
| 3 | DJO | Altivate Shoulder Prostheses Stem | K172351 |
Summary of technology comparison:
The intended use, design, and materials of the PRIMA Humeral System and PRIMA TT Glenoid are substantially equivalent to the ones of the predicate devices.
Non-clinical testing
Mechanical tests demonstrated that device performance fulfilled the intended use and that
8
the devices are substantially equivalent to the predicate devices.
Mechanical testing was performed on worst case components or constructs:
- Fatigue test of the humeral stem ●
- . Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, PRIMA Humeral System and PRIMA TT Glenoid are substantially equivalent to the predicate devices identified in this premarket notification.