SMR Stemless Anatomic

K221758 · Lima Corporate S.P.A. · PKC · Mar 17, 2023 · Orthopedic

Device Facts

• Record ID: K221758
• Device Name: SMR Stemless Anatomic
• Applicant: Lima Corporate S.P.A.
• Product Code: PKC · Orthopedic
• Decision Date: Mar 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to: · non-inflammatory degenerative joint disease including osteoarthritis; • revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant); · glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only). The SMR Stemless Anatomic is intended for uncemented use.

Device Story

Modular shoulder prosthesis system consisting of stemless core and humeral head adaptor taper. Designed for uncemented fixation in total primary or revision shoulder arthroplasty. Components are interchangeable to allow independent sizing and positioning. Compatible with previously cleared SMR humeral heads and various SMR glenoid components (metal back, all-polyethylene, and TT Hybrid). Used by orthopedic surgeons in clinical settings to replace diseased shoulder joints. Provides structural support and restores joint function; benefits patients by alleviating disability caused by degenerative joint disease or failed prior implants.

Clinical Evidence

Clinical evidence included an EU post-market study (n=62) and supplemental data from two published studies. Composite clinical success for the SMR Stemless Anatomic was 89.9% (95% 1-sided lower bound CI 83.2%) vs 92.3% (95% 1-sided lower bound CI 82.3%) for the Arthrex Eclipse control. Supplemental data (n=52) showed 96.2% composite clinical success (95% 1-sided lower bound CI 91.1%) and demonstrated adequate fixation of the stemless core at 24-month follow-up.

Technological Characteristics

Modular system with stemless core and humeral head adaptor taper. Designed for uncemented use. Performance characteristics verified via fatigue, pull-out, torque-out, micromotion, and range of motion testing. Compatible with existing SMR humeral heads and glenoid components.

Indications for Use

Indicated for total primary or revision shoulder joint replacement in patients with disability due to non-inflammatory degenerative joint disease (osteoarthritis), revision of previous shoulder surgeries (if fixation not compromised), or glenoid arthrosis (Walch A1, A2, B1).

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

• Arthrex Eclipse Shoulder Prosthesis Anatomic (K183194)

Reference Devices

• LimaCorporate S.p.A. SMR Shoulder System (K100858, K110598, K110847, K113254, K133349, K143256, K153722, K163397, K161476)
• Tornier, Inc. Simpliciti Shoulder System (K143552)
• Zimmer GmbH Sidus Stem-Free Shoulder (K171858)
• Exactech Inc. Exactech Equinoxe Stemless Shoulder (K173388)
• LimaCorporate S.p.A. PRIMA Humeral System (K212800)

Submission Summary (Full Text)

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March 17, 2023

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LimaCorporate S.p.A % David Mcgurl Vice President, Regulatory Affairs-Orthopedics Mcra, LLC. 803 7th Street NW, 3rd Floor Washington, District of Columbia 20001

#### Re: K221758

Trade/Device Name: SMR Stemless Anatomic Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: February 14, 2023 Received: February 14, 2023

### Dear David Mcgurl:

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

Sincerely,

Image /page/1/Figure/6 description: The image shows a digital signature. The signature is by Farzana Sharmin -S. The date of the signature is 2023.03.17. The time of the signature is 16:42:55 -04'00'.

For Jiping Chen, MD, PhD, MPH Division 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

510(k) Number (if known) K221758

Device Name SMR Stemless Anatomic

Indications for Use (Describe)

The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:

· non-inflammatory degenerative joint disease including osteoarthritis;

• revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);

· glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Stemless Anatomic is intended for uncemented use.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right:5px;"> <b style="font-size: 16px;">☑</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <b style="font-size: 16px;">☐</b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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# 510(k) Summary

| Device Trade Name: | SMR Stemless Anatomic |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | LimaCorporate S.p.A.<br>Via Nazionale, 52<br>33038 Villanova di San Daniele del Friuli<br>Udine, Italy |
| Contact: | Mr. Roberto Gabetta<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by: | Mr. Dave McGurl<br>Vice President, Regulatory Affairs - Orthopedics<br>MCRA, LLC<br>803 7th Street, NW, 3rd Floor<br>Washington, DC 20001<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | March 15, 2023 |
| Classification: | 21 CFR 888.3660 |
| Class: | II |
| Product Codes: | PKC |
| Primary Predicate Device: | Arthrex Eclipse Shoulder Prosthesis Anatomic (K183194) |
| Reference Devices: | LimaCorporate S.p.A. SMR Shoulder System (K100858,<br>K110598, K110847, K113254, K133349, K143256,<br>K153722, K163397, K161476)<br>Tornier, Inc. Simpliciti Shoulder System (K143552)<br>Zimmer GmbH Sidus Stem-Free Shoulder (K171858)<br>Exactech Inc. Exactech Equinoxe Stemless Shoulder<br>(K173388)<br>LimaCorporate S.p.A. PRIMA Humeral System (K212800) |

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#### Indications for Use:

The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:

- Non-inflammatory degenerative joint disease including osteoarthritis;
- . Revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);
- . Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Stemless Anatomic is intended for uncemented use.

#### Device Description:

The SMR Stemless Anatomic is a modular system comprised of a stemless core and humeral head adaptor taper. The modular components are available in various sizes and are interchangeable allowing for independent sizing and positioning. The SMR humeral heads were previously cleared (K161476, K100858), and the SMR Stemless Anatomic is compatible with the previously cleared Cemented SMR metal back Glenoid Components (K113254, K133349, K143256), Cemented SMR all polyethylene glenoid components (K100858, K130642, K153722), and SMR TT Hybrid Glenoid System (K163397).

#### Performance Testing:

The following testing was performed in support of the SMR Stemless Anatomic performance:

- Fatigue and Post Fatigue Pull-Out Testing
- Micromotion Testing ●
- Adaptor from Core Pull-Out Testing ●
- Head from Adaptor Pull-Out Testing
- Adaptor from Core Torque-Out Testing
- Head from Adaptor Torque-Out Testing ●
- Range of Motion
- Clinical Data

#### Clinical Data Summary:

Clinical data was provided from an EU post market study on 62 subjects who received the SMR Stemless Anatomic. The Arthrex Eclipse control data came from a published clinical study. The composite clinical success for SMR Stemless Anatomic is 89.9% (95% 1-sided lower bound confidence interval 83.2%) compared with the 92.3% (95% 1-sided lower bound confidence interval 82.3%) for the Arthrex Eclipse control group.

Additional supplemental data was provided, by obtaining patient level information from two published studies for the subject SMR stemless anatomic. The supplemental data was used to demonstrate adequate fixation of the stemless core at 24 month follow-up. Additionally, the composite clinical success was able to be calculated for one of the supplemental datasets (n=52). This composite clinical success for the SMR Stemless Anatomic was determined to be 96.2% (95% 1sided lower bound confidence interval 91.1%).

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#### Substantial Equivalence:

The SMR Stemless Anatomic is substantially equivalent in materials, indications, function and/or performance to the predicate device: Arthrex Eclipse Shoulder Prosthesis System (K183194).