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 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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

Device Description

The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:

It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.

Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Area	Acceptance Standard (Implicit from Substantial Equivalence and Standards)	Reported Device Performance (Summary from Document)
Mechanical Performance	Fatigue Test	Device must withstand anticipated physiological loads and cycles without failure or significant degradation over its intended lifespan, meeting relevant ISO/ASTM standards.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Push-Out Test	Components must maintain adequate fixation strength against physiological forces.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Wear Test	Wear rates of bearing surfaces (UHMWPE, CoCrMo) must be within acceptable limits as defined by relevant ISO/ASTM standards and comparable to predicate devices.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Creep and Deformation Test	Materials must exhibit acceptable levels of creep and deformation under sustained loads.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Micromotion Test	Interface micromotion between implanted components and bone must be within limits conducive to bone ingrowth and long-term stability.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Clean and Abrasive Wear Test	Evaluation of wear under specific conditions, ensuring material integrity.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Particle Analysis	Assessment of wear debris generated by the bearing surfaces to evaluate potential biological reactivity and long-term effects.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
	Range of Motion	The system should allow satisfactory physiological range of motion.	"Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices."
Biocompatibility	Biological Safety Evaluation	Biocompatibility (cytotoxicity, sensitization, irritation, etc.) must be established according to ISO 10993-1.	"A biological safety evaluation was conducted per FDA Guidance and ISO 10993-1." (Implicitly met acceptance criteria)
Material Compliance	Material Standards (e.g., Ti6Al4V, CoCrMo, UHMWPE)	All materials must conform to specified international standards (ISO, ASTM) for medical implants.	"Ti6Al4V (ISO 5832-3 - ASTM F1472) – Ti6Al4V 3D printed (to meet the mechanical and chemical requirements of ISO 5832-3) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - LimaVit™ (Vitamin E highly crosslinked UHMWPE) (ISO 5834-2 - ASTM F648 - ASTM F2695 – ASTM F2565) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)" (Confirmed compliance)
Sterility, Packaging, Shelf Life, Reprocessing	Validation against established standards.	Must be adequately validated.	"Previously completed sterility, packaging, shelf life and reprocessing validations from the predicate system were leveraged for the subject devices." (Implicitly met acceptance criteria by leveraging predicate data)
Clinical Performance (Substantial Equivalence)	Equivalence in safety and effectiveness to predicate device, as demonstrated through post-market data.	Clinical outcomes for the subject device (or its components) must be consistent with the known performance and safety profile of the predicate device.	"Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission, including patient-level radiographs, outcome measures, and safety data. The data supported a determination of substantial equivalence." (Implicitly met acceptance criteria)

Study Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.

4. Adjudication Method for the Test Set:

Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This device is an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.

7. The Type of Ground Truth Used:

Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.

8. The Sample Size for the Training Set:

Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.

Summary

FDA 510(k) Clearance Letter - SMR Reverse HP Shoulder System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 3, 2025

LimaCorporate S.p.A.
℅ Sarah Pleaugh
Director Regulatory Affairs
Mcra, LLC
803 7th Street NW, Third Floor
Washington, District of Columbia 20001

Re: K243826
Trade/Device Name: SMR Reverse HP Shoulder System
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX
Dated: June 4, 2025
Received: June 4, 2025

Dear Sarah Pleaugh:

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"

Page 2

K243826 - Sarah Pleaugh
Page 2

(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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K243826 - Sarah Pleaugh
Page 3

Sincerely,

Farzana Sharmin -S Digitally signed by Farzana Sharmin -S
Date: 2025.07.03 12:02:14 -04'00'

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

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

Indications for Use

510(k) Number (if known): K243826

Device Name: SMR Reverse HP Shoulder System

Indications for Use (Describe)

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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF

Page 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

Indications for Use

510(k) Number (if known): K243826

Device Name: SMR Reverse HP Shoulder System

Indications for Use (Describe)

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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

System	Components	Material	System Use
R			Cem
•	SMR Stem (Cemented Revision)	Ti6Al4V	X
•	SMR Stem (Cementless Revision)	Ti6Al4V
•	SMR Short Stem (Cementless Finned)	Ti6Al4V
•	SMR Reverse Humeral Body	Ti6Al4V	X
•	Humeral Extension	Ti6Al4V	X
•	SMR Glenosphere*	CoCrMo UHMWPE X-Lima + Ti6Al4V
•	SMR Connector*	Ti6Al4V UHMWPE	X
•	Reverse Liner	CoCrMo LimaVit™ (Vitamin E highly crosslinked UHMWPE)	X
• *	SMR TT Hybrid Glenoid	UHMWPE+ Ti6Al4V 3D printed +Ta	X
•	SMR TT Hybrid Glenoid Reverse Baseplate + Screw	Ti6Al4V
•	SMR Metal Back Glenoid	Ti6Al4V+PoroTi
•	SMR TT Baseplate	Ti6Al4V	X*
•	SMR TT Augmented 360 Baseplate	Ti6Al4V
•	SMR TT Glenoid Peg	Ti6Al4V 3D printed	X
•	SMR Bone screw	Ti6Al4V

Material Standards
Ti6Al4V (ISO 5832-3 - ASTM F1472) – Ti6Al4V 3D printed (to meet the mechanical and chemical requirements of ISO 5832-3) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - LimaVit™ (Vitamin E highly crosslinked UHMWPE) (ISO 5834-2 - ASTM F648 - ASTM F2695 – ASTM F2565) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF

Page 6

R=Reverse

NOTE:
• When considering the humeral side, SMR Glenosphere Ø42 can be coupled only with PRIMA Humeral System.
• 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 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.
• Glenosphere size must be chose according to clinical case, considering both joint dimension and soft tissues quality. In case of small shoulder join and/or stiff joint a smaller, surgeon should be prepared to use smaller glenosphere, such as 36 mm CoCrMo one.

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.

FORM FDA 3881 (6/20)
Page 2 of 2

Page 7

Page 1 of 4
K243826
LimaCorporate S.p.A.

510(k) Summary K243826

Device Trade Name: SMR Reverse HP Shoulder System

Manufacturer: LimaCorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine, Italy

Contact: Marco Tallerico
Regulatory Geographical Expansion Lead
39-043-294-5500
marco.tallerico@enovis.com

Prepared by: MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Office: 202.552.5800

Date Prepared: July 2, 2025

Classifications: 21 CFR 888.3660; Shoulder joint metal/polymer, semi-constrained, cemented prosthesis

Class: II

Product Codes: PHX

Primary Predicate: LimaCorporate SMR Shoulder System (K223876)

Reference Devices: LimaCorporate SMR Reverse System (K100858/K110598/K142139)
LimaCorporate Delta TT Acetabular System (K112898)

Device Description:
The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

Page 8

Page 2 of 4
K243826
LimaCorporate S.p.A.

Indications For Use:

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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

System	Components	Material	System Use
R			Cem
•	SMR Stem (Cemented Revision)	Ti6Al4V	X
•	SMR Stem (Cementless Revision)	Ti6Al4V
•	SMR Short Stem (Cementless Finned)	Ti6Al4V
•	SMR Reverse Humeral Body	Ti6Al4V	X
•	Humeral Extension	Ti6Al4V	X
•	SMR Glenosphere*	CoCrMo UHMWPE X-Lima + Ti6Al4V
•	SMR Connector*	Ti6Al4V UHMWPE	X
•	Reverse Liner	CoCrMo LimaVit™ (Vitamin E highly crosslinked UHMWPE)	X
• *	SMR TT Hybrid Glenoid	UHMWPE+ Ti6Al4V 3D printed +Ta	X
•	SMR TT Hybrid Glenoid Reverse Baseplate + Screw	Ti6Al4V
•	SMR Metal Back Glenoid	Ti6Al4V+PoroTi
•	SMR TT Baseplate	Ti6Al4V	X*
•	SMR TT Augmented 360 Baseplate	Ti6Al4V
•	SMR TT Glenoid Peg	Ti6Al4V 3D printed	X
•	SMR Bone screw	Ti6Al4V

R=Reverse

Indications For Use:

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 Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

System	Components	Material	System Use
R			Cem
•	SMR Stem (Cemented Revision)	Ti6Al4V	X
•	SMR Stem (Cementless Revision)	Ti6Al4V
•	SMR Short Stem (Cementless Finned)	Ti6Al4V
•	SMR Reverse Humeral Body	Ti6Al4V	X
•	Humeral Extension	Ti6Al4V	X
•	SMR Glenosphere*	CoCrMo UHMWPE X-Lima + Ti6Al4V
•	SMR Connector*	Ti6Al4V UHMWPE CoCrMo LimaVit™ (Vitamin E highly crosslinked UHMWPE)	X
•	Reverse Liner	UHMWPE+ Ti6Al4V 3D printed +Ta	X
• *	SMR TT Hybrid Glenoid	Ti6Al4V
•	SMR TT Hybrid Glenoid Reverse Baseplate + Screw	Ti6Al4V+PoroTi
•	SMR Metal Back Glenoid	Ti6Al4V	X*
•	SMR TT Baseplate	Ti6Al4V
•	SMR TT Augmented 360 Baseplate	Ti6Al4V 3D printed	X
•	SMR TT Glenoid Peg	Ti6Al4V
•	SMR Bone screw

R=Reverse

Page 2 of 4
K243826
LimaCorporate S.p.A.

Page 9

Page 3 of 4
K243826
LimaCorporate S.p.A.

*NOTE:
• When considering the humeral side, SMR Glenosphere Ø42 can be coupled only with PRIMA Humeral System.
• 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 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.
• Glenosphere size must be chose according to clinical case, considering both joint dimension and soft tissues quality. In case of small shoulder join and/or stiff joint a smaller, surgeon should be prepared to use smaller glenosphere, such as 36 mm CoCrMo one.

Performance Testing Summary:

Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices are substantially equivalent to the predicate devices. Mechanical testing was performed on worst case components or constructs:
• Fatigue test
• Push-Out test
• Wear test
• Creep and Deformation test
• Micromotion test
• Clean and Abrasive Wear test
• Particle Analysis
• Range of Motion

A biological safety evaluation was conducted per FDA Guidance and ISO 10993-1. Previously completed sterility, packaging, shelf life and reprocessing validations from the predicate system were leveraged for the subject devices.

Clinical Testing Summary:

Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission, including patient-level radiographs, outcome measures, and safety data. The data supported a determination of substantial equivalence.

Page 3 of 4
K243826
LimaCorporate S.p.A.

Page 10

Page 4 of 4
K243826
LimaCorporate S.p.A.

Predicate Devices:

LimaCorporate submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject SMR Reverse HP Shoulder System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:

• Primary Predicate: LimaCorporate SMR Shoulder System (K223876)
• Reference Device: LimaCorporate SMR Reverse System (K100858/K110598/K142139)
• Reference Device: LimaCorporate Delta TT Acetabular System (K112898)

Substantial Equivalence:

The intended use, design, and materials of the SMR Reverse HP System are substantially equivalent to the ones of the manufacturer's own, legally marketed predicate devices. The primary predicate is the same intended use, overall design and fundamental technology as the subject system. In contrast to the primary predicate SMR Shoulder System (K223876), which uses a glenosphere component manufactured of CoCrMo alloy and a humeral liner manufactured from UHMWPE, the subject SMR Reverse HP Shoulder System utilizes a glenosphere component manufactured from crosslinked UHMWPE and a humeral liner manufactured form CoCrMo alloy.

Reference devices provide supporting safety and effectiveness evidence for mechanical and clinical performance, UHMWPE material (K112898) and UHMWPE / CoCrMo bearing surface (K100858).

Conclusion:

Based upon comparison of intended use, materials, summary of technological characteristics, non-clinical testing, and clinical testing, the SMR Reverse HP Shoulder System is substantially equivalent to the predicate device identified in this premarket notification.

Page 4 of 4
K243826
LimaCorporate S.p.A.

Regulation Number and Section

§ 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.”