(274 days)
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.
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).
This document is a 510(k) clearance letter from the FDA for a medical device called the "SMR Stemless Anatomic." It's not a study report of an AI/ML powered medical device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML product.
The document discusses performance testing for a mechanical orthopedic implant, specifically a shoulder joint prosthesis, covering aspects like fatigue, micromotion, and pull-out strength. It also mentions "Clinical Data" related to the device's success in patients, comparing it to a predicate device. This is a traditional medical device clearance, not an AI/ML software as a medical device (SaMD) or AI-powered medical device.
Therefore, I cannot extract the requested information (table of acceptance criteria with AI performance, sample sizes for AI test sets, expert details for AI ground truth, MRMC studies, etc.) from this document. The concepts and methodologies described in the prompt are specific to the evaluation and clearance of AI/ML-driven medical devices, which this document does not concern.
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March 17, 2023
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Device Trade Name: | SMR Stemless Anatomic |
|---|---|
| Manufacturer: | LimaCorporate S.p.A.Via Nazionale, 5233038 Villanova di San Daniele del FriuliUdine, Italy |
| Contact: | Mr. Roberto GabettaPhone: +39 338 6439379Fax: +39 0432 945511Roberto.gabetta@limacorporate.com |
| Prepared by: | Mr. Dave McGurlVice President, Regulatory Affairs - OrthopedicsMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Phone: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com |
| 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,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) |
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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).
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
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.”