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;
. 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 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.

Device Description

Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.

The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg made of Trabecular Titanium, intended for uncemented use with the addition of bone screws for fixation to the bone. This glenoid component is part of the SMR TT Augmented Glenoid System (K191746/K200171) that is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding Bone Screws dia. 5,0 mm manufactured by LimaCorporate S.p.A. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not contain details about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these elements are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools. This document pertains to the substantial equivalence determination of a bone screw, which is a mechanical implant, and its evaluation relies on mechanical testing and comparison to predicate devices, not data-driven performance metrics for an algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as this information is not present. The document explicitly states:

"Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device." This confirms that there was no clinical study with a test set of patient data, human readers, or ground truth as you described.
The testing performed was "Mechanical testing" which demonstrated the device's ability to perform substantially equivalent to the predicate device in:
- Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)

In summary, the provided document is for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, test sets, training sets, expert consensus, MRMC studies, and ground truth are not applicable to the content of this FDA 510(k) premarket notification.

Summary

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Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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

Re: K210717

Trade/Device Name: Bone Screws dia. 5,0 mm Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, MBF, KWS, KWT Dated: June 7, 2021 Received: June 8, 2021

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

July 12, 2021

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Owens 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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Indications for Use

510(k) Number (if known)

K210717

Device Name Bone Screws dia. 5,0 mm

Indications for Use (Describe)

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indical, 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 coff deficient joint with severe arthropathy (disabled shoulder). 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 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 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 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 with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere/glenosphere construct. On the glenoid side, the fixation of all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

System		Components	Material	Use
A	R			Cem	NotCem
●	●	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

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•		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) & O-Al-V (ISO 5832-12, ASTM F1580) - UHMWPE (ISO 5834-2, ASTM F648) - PoroTi - Ti+Tantalum

Ti6A4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) - UHMWPE (ISO 5834-2 - ASTM F648) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)

A= Anatomic / R=Reverse

*NOTE:

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 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 cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Summary of Safety and Effectiveness

Date: February 22, 2021

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

U.S. Contact Person: Lacey Harbour lacey.harbour@limacorporate.com Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377

Product	ProductCode	Regulation and Classification Name
Bone Screws dia.5,0 mm	PHX	Shoulder Prosthesis, Reverse Configuration per 21CFR 888.3660
	MBF	Shoulder joint metal/polymer/metalnonconstrained or semi-constrained porous-coated uncemented prosthesis per 21 CFR888.3670
	KWS	Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer Cemented per 21 CFR 888.3660
	KWT	Prosthesis, Shoulder, Non-Constrained,Metal/Polymer Cemented per 21 CFR 888.3650

Description:

Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone.

Intended Use:

Bone Screws dia. 5,0 mm have the same indication for use of those of the system with which they are used.

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Indications for Use

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;
. 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 TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

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	Use
A	R				Cem	NotCem

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●	●	SMR Stems (Cemented, Cemented Revision)	Ti6Al4V	X
●	●	SMR Stems (Cementless Finned, Cementless Revision)	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 Baseplate	Ti6Al4V		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

A= Anatomic / R=Reverse

*NOTE:

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 54 mm Humeral Heads with + 3 mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The dia. 52 mm and 54 mm Humeral Heads with + 2 mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

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Predicate Devices:

SMR TT Augmented Glenoid System (Limacorporate, K191746/K200171) ●
. Tornier 5.0mm peripheral screw (K161742)

Summary of technology comparison:

Bone Screws dia. 5.0 mm are identical in material, manufacturing process, packaging. sterilization to the Bone screws dia. 4,5 mm and Bone Screws dia. 6,5 mm cleared in K191746/K200171.

The indications for use for Bone Screws dia. 5,0 mm are the same as the indications for use of the system with which they are used to.

Non-clinical testing

Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate device in:

Torsional test, driving torque test, pull-out test for bone screws (ASTM F543)
Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)

Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of Bone Screws dia. 5,0 mm to the predicate device.

Conclusions

The 5,0 mm Bone Screws (Subject Device System) described in this section has an equivalent intended use and same functional technology as previously cleared bone screws, primarly the ones described in K200171. Based on the testing data provided and description of the differences between the subject and predicated devices. LimaCorporate concludes that the subject device is substantially equivalent to the predicate device.

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.”