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 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.

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

The 45mm length SMR Finned Short Stems are available in 13 diameters and are for coupling with previously cleared Reverse Humeral Bodies (K110598) or Humeral Bodies (K100858, K101263); they are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a male taper.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding LimaCorporate S.p.A.'s SMR Finned Short Stems. It details the device's intended use, description, and comparison to predicate devices, focusing on demonstrating substantial equivalence for a medical device that is a physical orthopedic implant.

Crucially, this document does not describe an AI/software as a medical device (SaMD) or any device that relies on algorithms for diagnostic or therapeutic decisions. Therefore, the concepts of acceptance criteria for algorithm performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical (mechanical) testing for the physical implant, not a clinical trial involving patient data and algorithm performance.

Here's a breakdown based on the provided document, addressing the prompt's categories where applicable, and explicitly stating when information is R/NA (Refers to Not Applicable) due to the nature of the device:

Acceptance Criteria and Device Performance (for a physical orthopedic implant)

There isn't a direct "acceptance criteria table" for algorithm performance as would be seen in an AI/SaMD submission. Instead, the acceptance criteria are met through mechanical testing that demonstrates the new device performs similarly to or better than predicate devices in terms of structural integrity and function.

Acceptance Criteria (Implied for Physical Device)	Reported Device Performance
Fatigue-fretting behavior: Must be comparable to or better than predicate devices and suitable for intended use.	Fulfilled: Mechanical tests demonstrated that device performance fulfilled the intended use. Specifically, "fatigue-fretting behaviour of the new SMR Finned Short Stems" was evaluated.
Residual torque of safety screw and push-out force of coupling between stem and humeral body: Must meet established thresholds for secure coupling.	Fulfilled: Mechanical tests demonstrated that device performance fulfilled the intended use. "Evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body" was performed.
Substantial Equivalence: Must be substantially equivalent to predicate devices in intended use, design, and materials.	Claimed: "The intended use, design, and materials of the SMR Finned Short Stems are substantially equivalent to the ones of the predicate devices." "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices."

Detailed breakdown of the study (non-clinical testing for a physical implant):

A table of acceptance criteria and the reported device performance:
- See the table above. These are implicit criteria for mechanical performance of an orthopedic implant for substantial equivalence.
Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document in terms of number of physical stems tested. It refers to "worst case components or constructs."
- Data Provenance: This refers to the testing of physical samples of the manufactured SMR Finned Short Stems. "Worst case components or constructs identified through FE analysis" were tested. This is a form of prospective, in-vitro testing. (R/NA for geographic provenance as it's mechanical testing of manufactured parts).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- R/NA: This is not an AI/SaMD submission requiring expert consensus for ground truth on medical images or diagnoses. The "ground truth" for a physical implant's performance is derived from standardized mechanical testing protocols and engineering principles.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- R/NA: This concept applies to human assessment of data, often in AI/SaMD studies to resolve discrepancies. It is not relevant for mechanical testing of a physical implant.
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:
- R/NA: This is specifically for AI/SaMD devices. No such study was performed or required as this is a physical medical device. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR Finned Short Stems to the predicate devices."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- R/NA: This is for AI/SaMD devices. The device is a physical shoulder implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: For a physical implant, the "ground truth" is established by engineering standards and mechanical properties. This includes successful completion of "fatigue-fretting behaviour" and "evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body" based on established engineering test methods and design specifications.
The sample size for the training set:
- R/NA: This is for AI/SaMD devices. This device does not have a "training set." The design and "worst case components" for mechanical testing might be identified through engineering analysis (e.g., Finite Element Analysis as mentioned "FE analysis"), but this is not an AI training process.
How the ground truth for the training set was established:
- R/NA: As there is no training set for this physical device, this question is not applicable.

Summary

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October 10, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an eagle with outstretched wings, while the FDA part has the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

LimaCorporate S.p.A % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K191963

Trade/Device Name: SMR Finned Short Stems Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder Joint Metal/Polymer/Metal Nonconstrained Or Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBF, PHX, KWS, KWT, HSD Dated: July 12, 2019 Received: July 23, 2019

Dear Stephen Peoples:

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

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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 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,

for Michael Owens 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) K191963

Device Name SMR Finned Short Stems

Indications for Use (Describe)

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint o 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; 0
inflammatory degenerative joint disease such as rheumatoid arthritis; ●
treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation O methods;
revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock O remains;
0 cuff tear arthropathy (CTA Heads only);
glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch 0 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.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.

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				Use
A	R	Components	Material	Cem	NotCem
•	•	SMR Stems (Cemented, CementedRevision)	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 ReverseHumeral 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 ReverseBaseplate + Screw	Ti6Al4V		X
•	•	SMR Metal Back Glenoids	Ti6Al4V+PoroTi	X*	X*
•	•	SMR TT Baseplate	Ti6Al4V	X*	X*
•	•	SMR TT Glenoid Peg	Ti6Al4V	X	X
•		SMR Metal Back Liner	UHMWPE	X*	X*
•	*	SMR Bone screws	Ti6Al4V		X

5834-2 - ASTM F648) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)

A= Anatomic / R=Reverse

*NOTES:

In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR 0 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 0 SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
0 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 O 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.

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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).

And Annual Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Chil
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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Summary of Safety and Effectiveness

Date: July 12, 2019

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

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant SPeoplesVMD@gmail.com PEOPLES & ASSOCIATES CONSULTING, LLC 411 Auditorium Blvd. Winona Lake, IN 46590 Phone: 260-645-0327 FAX: +39 0432945512

Product	Product Code	Regulation and Classification Name
	MBF	Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer, Uncemented per 21 CFR888.3670
	HSD	Prosthesis, Shoulder, Hemi-, Humeral,Metallic Uncemented per 21 CFR 888.3690
SMR Finned Short Stems(included in SMRShoulder System)	PHX	Shoulder Prosthesis, Reverse Configurationper 21 CFR 888.3660
	KWS	Prosthesis, Shoulder, Semi-Constrained,Metal/Polymer Cemented per 21 CFR888.3660
	KWT	Prosthesis, Shoulder, Non-Constrained,Metal/Polymer Cemented per 21 CFR888.3650

Description:

Intended 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; in case of SMR Short Stems only if sufficient bone

Traditional 510(k) - SMR Finned Short Stems September 23rd, 2019

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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 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.

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.

System		Components	Material	Use
A	R			Cem	NotCem
•	•	SMR Stems (Cemented, CementedRevision)	Ti6Al4V	X
•	•	SMR Stems (Cementless Finned,Cementless Revision)	Ti6Al4V		X
•	•	SMR Short Stems (CementlessFinned)	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 ReverseHumeral Body	Ti6Al4V	X	X
•	•	SMR Glenospheres	CoCrMo		X
•	•	SMR Connectors*	Ti6Al4V		X

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		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 ReverseBaseplate + Screw	Ti6Al4V		X
	●	SMR Metal Back Glenoids	Ti6Al4V+PoroTi	X*	X*
	●	SMR TT Baseplate	Ti6Al4V	X*	X*
	●	SMR TT Glenoid Peg	Ti6Al4V	X	X
	●	SMR Metal Back Liner	UHMWPE	X*	X*
*	●	SMR Bone screws	Ti6Al4V		X
Material Standards

Material Standards

Ti6Al4V (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

*NOTES:

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).

Predicate Devices:

Company	Device name	Cleared via
LIMACORPORATE	SMR Finned stems	K101263

Traditional 510(k) - SMR Finned Short Stems September 23rd, 2019

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	(part of the Limacorporate SMRShoulder System)
BIOMET	Comprehensive Primary ShoulderHumeral stems	K060692
WRIGHT (TORNIER)	AEQUALIS ASCEND™ Flex Humeralstems	K122698

Summary of technology comparison:

The intended use, design, and materials of the SMR Finned Short Stems are substantially equivalent to the ones of the predicate devices. Design Control Activities have been successfully completed.

Non-clinical testing

Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices.

Mechanical testing was performed on worst case components or constructs identified through FE analysis:

fatigue-fretting behaviour of the new SMR Finned Short Stems; ●
. evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body.

Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR Finned Short Stems to the predicate devices.

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”