PRIMA Humeral System and SMR Glenosphere Ø42

K212800 · Lima Corporate S.P.A. · PHX · Feb 25, 2022 · Orthopedic

Device Facts

• Record ID: K212800
• Device Name: PRIMA Humeral System and SMR Glenosphere Ø42
• Applicant: Lima Corporate S.P.A.
• Product Code: PHX · Orthopedic
• Decision Date: Feb 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Stem is 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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, 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 and reverse insert. The PRIMA Humeral System is intended to be used with all SMR glenoids implants. 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 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.

Device Story

PRIMA Humeral System and SMR Glenosphere Ø42 are modular shoulder arthroplasty components; used for primary or revision total/partial shoulder replacement. System includes humeral stems, bodies, adaptors, heads, reverse trays, and inserts. Inputs: patient anatomy; surgeon selects components based on anatomic or reverse configuration. Operation: mechanical assembly of modular components; stem fixation via cement or cementless (Trabecular Titanium) methods. Output: reconstructed shoulder joint. Used in clinical/surgical settings by orthopedic surgeons. Benefits: restoration of joint function, pain relief, and correction of deformity in patients with rotator cuff deficiency or degenerative disease. Output affects clinical decision-making by providing modular options for conversion between anatomic and reverse configurations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: fretting fatigue, fatigue testing on polyethylene liners, dynamic evaluation of glenoid loosening/disassociation (ASTM F2028), coupling resistance (push-out, lever-out, torque-out), wear testing (ISO 14242-2, ASTM F2003), biocompatibility (ISO 10993-1), endotoxin assessment, and sterilization/packaging validation.

Technological Characteristics

Materials: Ti6Al4V (ISO 5832-3, ASTM F1472), CoCrMo (ISO 5832-12, ASTM F1537), UHMWPE (ISO 5834-2, ASTM F648), PoroTi Titanium (ASTM F1580), Tantalum (ISO 13782, ASTM F560). Modular design for anatomic/reverse configurations. Fixation: cemented or cementless (Trabecular Titanium). Sterilization: Radiation (metal), EtO (poly). Connectivity: N/A (mechanical).

Indications for Use

Indicated for skeletally mature patients requiring partial or total, primary or revision shoulder joint replacement. Conditions include non-inflammatory/inflammatory degenerative joint disease (osteoarthritis, rheumatoid arthritis), avascular necrosis, traumatic/post-traumatic arthritis, humeral head fractures, post-fracture deformity, cuff tear arthropathy, and massive irreparable rotator cuff tears. Requires functional deltoid muscle and adequate bone stock/fixation. Contraindicated for SMR TT Hybrid Glenoid Reverse Baseplate in cases of excessive glenoid bone loss or when bone graft is needed.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• DJO AltiVate Reverse Humeral Stem (K190290)
• DJO AltiVate Anatomic Shoulder System (K162024)
• DJO AltiVate Reverse Humeral Stem, Small Spacer, Small Hemi-Adapter, Small Socket Insert (K172351)
• DJO AltiVate Anatomic to Reverse Conversion Module (K173073)
• TORNIER Aequalis Ascend Flex (K122698)
• TORNIER PERFORM Humeral System - Stem (K201315)
• LimaCorporate SMR Reverse Shoulder System (K110598)

Reference Devices

• TORNIER Glehosphere (K081016)

Submission Summary (Full Text)

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February 25, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

LimaCorporate S.p.A. % Lacey Harbour US Regulatory Manager Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006

Re: K212800

Trade/Device Name: PRIMA Humeral System and SMR Glenosphere Ø42 Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, HSD, PAO Dated: January 21, 2022 Received: January 25, 2022

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 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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Lixin Liu, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K212800

#### Device Name

PRIMA Humeral System and SMR Glenosphere Ø42

Indications for Use (Describe)

#### 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 Stem is 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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,
- . 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:

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- Anatomic configuration: ●
- stem
- adaptor for humeral heads. ı
- Reverse configuration:
- । stem
- i reverse tray and
- । reverse insert.

The PRIMA Humeral System is intended to be used with all SMR glenoids implants.

# SMR Glenosphere Ø42

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 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 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 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, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

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| System | | Components | Material | System use | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------|------------|-----------|
| A | R | | | Cem | No<br>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 | |
| • | • * | 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 | | | | |

## A= Anatomic / R=Reverse

*NOTE:

- When considering the humeral side, SMR Glenosphere Ø42 can be coupled only with PRIMA Humeral . System.

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- 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 + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: 400;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: 400;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="display: inline !important;"> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

Date: August 25th, 2021

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy

U.S. Contact Person: Lacey Harbour [e-mail] Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Office Phone: [phone] ext.200 Cell Phone: [phone] FAX: [phone]

| Product | Product Code | Regulation and Classification Name |
|-------------------------|--------------|-------------------------------------------------------------------------------------------|
| PRIMA Humeral<br>System | HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic<br>Uncemented per 21 CFR 888.3690 |
| | PAO | Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis, per 21 CFR 888.3660 |
| | PHX | Shoulder Prosthesis, Reverse Configuration per 21 CFR<br>888.3660 |
| | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer<br>Cemented per 21 CFR 888.3660 |
| | KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer<br>Cemented per 21 CFR 888.3650 |
| SMR Glenosphere<br>Ø42 | HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic<br>Uncemented per 21 CFR 888.3690 |
| | PHX | Shoulder Prosthesis, Reverse Configuration per 21 CFR<br>888.3660 |
| | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer<br>Cemented per 21 CFR 888.3660 |
| | KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer<br>Cemented per 21 CFR 888.3650 |

Name of the Device

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| Product | Name of the device | Common or usual name of the device |
|-------------------------|----------------------|------------------------------------|
| PRIMA Humeral<br>System | PRIMA Humeral System | Humeral shoulder prosthesis |
| SMR Glenosphere<br>Ø42 | SMR Glenosphere Ø42 | Glenoid shoulder prosthesis |

The PRIMA Humeral System is the subject of this 510(k) and includes the SMR Glenosphere Ø42.

### Description:

The PRIMA Humeral System is the subject of this 510(k) and includes the SMR Glenosphere Ø42.

The PRIMA Stem is a convertible short stem component with proximal fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the short stem component (Ti6Al4V) can be coupled with an Adaptor for the humeral heads (Ti6Al4V) in case on anatomic system and with a Reverse Tray (Ti6Al4V) and Reverse Insert (LimaVit E UHMWPE Ti6A14V ring) only in case of reverse. The PRIMA Stem is intended for use in cementless and cemented applications, at the discretion of the surgeon.

When used in reverse configuration, the PRIMA Stem is coupled with a Glenosphere through a Reverse Tray and a Reverse Insert. PRIMA Stem is compatible with already cleared SMR Glenospheres Ø36 and Ø40 (K110598, K163397). In addition, PRIMA Stem is compatible with the new SMR Glenosphere Ø42 (CoCrMo), subject of the present 510(k).

#### 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 and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Stem is 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.

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- 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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.
- 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 and ।
- reverse insert. ।

The PRIMA Humeral System is intended to be used with all SMR glenoid implants.

## SMR Glenosphere Ø42

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;

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- 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 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 consists peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

| System | | Components | Material | System use | |
|--------|---|----------------------------------------------------|----------|------------|---------|
| A | R | | | 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 |

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| System | | | | System use | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------|-------------------|------------|------------|
| A | R | Components | Material | Cem | Not<br>Cem |
| | ● | 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<br>F648) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560) | | | | | |

#### A= Anatomic / R=Reverse

*NOTE:

- When considering the humeral side, SMR Glenosphere Ø42 can be coupled only with PRIMA Humeral System.
- 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 + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

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#### Predicate Devices:

The PRIMA Humeral System is substantially equivalent in materials, indications, function and/or performance to the following predicate devices:

| Product | Primary predicate devices | Additional predicate devices |
|-------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRIMA<br>Humeral System | DJO:<br>AltiVate Reverse Humeral<br>Stem (K190290) | DJO, AltiVate Anatomic™ Shoulder System (K162024) DJO, AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351) DJO, AltiVate Anatomic to Reverse Conversion Module (K173073) TORNIER, Aequalis Ascend Flex (K122698) TORNIER, PERFORM Humeral System - Stem (K201315) |

The following predicate devices were chosen for the subject SMR Glenosphere Ø42:

| Product | Primary predicate devices | Other predicate devices |
|---------------------------|-------------------------------------------------------------|--------------------------------------------|
| SMR<br>Glenosphere<br>Ø42 | LimaCorporate Spa, SMR Reverse<br>Shoulder System (K110598) | TORNIER, Aequalis Ascend<br>Flex (K122698) |

#### Summary of technology comparison:

PRIMA Humeral System is substantially equivalent to the predicate devices identified. The PRIMA Stem has many design features similar to the predicates, as the minimal lateral length, the humeral neck angle, the option to couple with the other components, antirotational stability solutions, and the porous coating. The porous coating is a Trabecular Titanium external structure, which is the same Trabecular Titanium structure of the device previously cleared via K133349.

All devices are made of the same metal material.

The Reverse Insert has same design of the PERFORM Humeral System (K201315), and the other predicates have similar features. The subject device is made of Vit E poly as the predicates K162024, K172351, K173073, K190290 and of metal as the predicate K122698. The Reverse Insert has more diameters as the predicate devices K162024. K172351, K173073, K190290 and has more thicknesses as the predicate K122698.

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The reverse tray has the same features of the basic ones of the PERFORM Humeral System , is made of the same material, but has more sizes as the PERFORM Humeral System. The adaptor has a double male taper and an eccentricity as the PERFORM Humeral System; both are made of titanium and have different sizes and offsets.

All components are provided sterile. The methods used for the subject devices are commonly used in orthopedic prosthesis and are the same used for the predicates K162024. K172351. K173073. K190290: rays for metal components. EtO for poly components.

SMR Glenosphere Ø42 has identical technological characteristics and design of K110598, except for the new diameter size, that is the same of the Tornier Glehosphere (K081016).

The predicates and the PRIMA Humeral System have substantially equivalent intended uses and indications for use. In details, all indications for use of PRIMA Humeral System are the same provided for the DJO Altivate predicate. The TORNIER Aequalis Ascend Flex has the most of indication for use provided for the subject devices, except only for the "avascular necrosis of the humeral head" and for the "Cuff tear arthropathy" in anatomic configuration, and for the "Rotator cuff tear arthropathy" in reverse configuration. The TORNIER PERFORM Humeral System has similar indication for use then the subject devices, with few exceptions.

The indications for use for the subject SMR 42mm Glenosphere are identical to the indications for use of predicate device, K110598 the Limacorporate SMR Reverse Shoulder System; both the subject device and predicate K110598 are intended to be used for reverse shoulder replacement using components of the SMR Reverse Shoulder System according to the indications for use described for the SMR Reverse Shoulder System cleared via K110598. The indications for use of the subject device are also like those of the other cited predicate.

All subject and predicate devices have the same stem fixation.

#### Non-clinical testing

The following tests are performed in support of the PRIMA Humeral System and SMR Glenosphere Ø42 performance:

- Fretting Fatigue in anatomic and reverse configuration; ●
- Fatigue test on polyethylene liner; ●
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028); ●
- . Coupling resistance under static load: push-out, lever-out and torque-out tests;
- Wear test, as per ISO 14242 - 2 and ASTM F2003;
- Biocompatibility evaluation, as per ISO 10993-1; ●
- Endotoxin assessment, as per ANSI/AAMI ST72; ●
- Packaging and shelf life validation as per ISO 11607-1/-2; ●
- Sterilization validation, as per ISO 11137-1/-2/-3.

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#### Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and SMR Glenosphere Ø42.

# Conclusion

Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, PRIMA Humeral System and SMR Glenosphere Ø42 are substantially equivalent to the respective predicate devices identified in this premarket notification.