The Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.

Device Description

The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.

The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The distal end of the humeral component is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the anterior / posterior direction for fixation using bone screws.

The proximal portion of the humeral component has a plasma sprayed commercially pure Titanium (CP Ti) coating and a hydroxyapatite (HA) coating. A hole in the proximal portion of the humeral component allows attachment to instrumentation designed to provide correct positioning (height and retroversion) of the implant. The humeral stem is available in sizes 8 - 15.

The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.

The double taper connector is manufactured from Ti-6A1-4V allor conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads. The double taper connector has a male taper on each end and is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the connector.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 54mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem.

The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.

The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to Ti-6Al-4V alloy conforming to ISO 5832-3.

AI/ML Overview

The provided text describes the Humelock II Cementless Shoulder System, a hemi-shoulder replacement system. The document is a 510(k) summary submitted by Fx Solutions to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the mechanical testing performed to support this claim in lieu of clinical testing.

Here's the information requested based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for the mechanical tests or reported device performance in a quantitative manner. It describes the types of tests conducted and their purpose.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Demonstrate fatigue strength of the humeral stem.	Mechanical testing was conducted to demonstrate the fatigue strength of the humeral stem. (Implied that the device met acceptable fatigue limits, though no specific values are given.)
Demonstrate stability of the modular connection between the double taper connector and the humeral stem.	Mechanical testing was conducted to demonstrate the stability of the modular connection between the double taper connector and the humeral stem. (Implied that the modular connection was stable.)
Evaluate pull-off strength of the humeral head from the taper.	Pull-off testing of the humeral head from the taper was conducted previously. (Implied results were acceptable, no specific values given.)
Characterize CP Titanium plasma spray coating.	Characterization data was provided for the CP Titanium plasma spray coating. (Implied coating met specifications, no specific data provided.)
Characterize hydroxyapatite coating.	Characterization data was provided for the hydroxyapatite coating. (Implied coating met specifications, no specific data provided.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing" was conducted. This refers to non-clinical, in-vitro laboratory testing of device components, not clinical studies involving human patients. Therefore, terms like "test set," "data provenance," "retrospective or prospective," "country of origin," and "sample size" in relation to human data are not applicable here. The "sample size" for the mechanical tests would refer to the number of physical device units or components tested, which is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As described above, this submission relies on non-clinical mechanical testing, not clinical data requiring expert evaluation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This submission relies on non-clinical mechanical testing, not clinical data requiring adjudication.

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

Not applicable. This submission relies on non-clinical mechanical testing. There is no mention of AI or human readers.

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

Not applicable. This submission relies on non-clinical mechanical testing. There is no mention of an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical mechanical testing would be the physical properties and performance observed during the tests (e.g., maximum load before failure, fatigue life, adhesion strength of coatings) as measured by calibrated equipment according to predefined test protocols and engineering standards (e.g., ISO standards mentioned for materials). There is no "expert consensus" or "pathology" in this context.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is a traditional medical device submission based on mechanical testing and substantial equivalence, not an AI/ML device requiring training data.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or corresponding ground truth as this is not an AI/ML device.

Summary

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3. 510(k) Summary
Prepared On:	March 18, 2013
Applicant / Sponsor:	Fx Solutions1663 rue de Majornas01440 ViriatFrance	NOV 09 2013
Manufacturer:	Compagnie Financière & Médicale13 Bd Victor Hugo01000 Bourg En BresseFrance
Contact:	Jean-Jacques Martin+33 4 74 55 35 55www.fxsolutions.fr
Proprietary Name:	Humelock II Cementless Shoulder System
Common Name:	Hemi-Shoulder Replacement System
Classification Names:	21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis, Class II
Product Codes:	HSD
Substantially Equivalent Devices:	K992525 - Acumed Modular Shoulder System
	K111097 - Fx Solutions Humelock Cemented ShoulderProsthesis
	K060874 - DePuy Global AP Shoulder System
	K103835 - Howmedica Osteonics ReUnion TSA System

Device Description:

The Humelock II Cementless Shoulder System is a hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, cortical bone screws and an

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optional protector and hex screw to prevent bone ingrowth into the threaded hole in the proximal stem.

The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral·head.

The cortical bone screws are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and are available with a diameter of 4.5mm in lengths of 18 - 40mm in 2mm increments.

The screw hole protector and hex screw are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.

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Intended Use / Indications:

Summary of Technologies/Substantial Equivalence:

Substantial equivalence of the Humelock II Cementless Shoulder Prosthesis to the predicate devices is based on a comparison of indications, intended use, materials, design and sizing, and mechanical testing.

Non-Clinical Testing:

Mechanical testing was conducted to demonstrate the fatigue strength of the humeral stem and the stability of the modular connection between the double taper connector and the humeral stem. Pull off testing of the humeral head from the taper was conducted previously. Characterization data was provided for the CP Titanium plasma sprav coating and the hydroxvapatite coating.

Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cementless Shoulder System and the predicate shoulder systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 9, 2013

Fx Solutions Mr. Jean-Jacques Martin 1663 Rue De Maiornas 01440 Viriat France

Re: K130759

Trade/Device Name: Humelock II Cementless Shoulder System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: October 3, 2013 Received: October 8, 2013

Dear Mr. Martin:

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. 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 docs 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 four d 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jean-Jacques Martin

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, picase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely yours.

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for

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K130759

Device Name: Humelock II Cementless Shoulder System

Indications for Use:

Over-The-Counter Use _ . Prescription Use -X-AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE),

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Casey L. Hanley, Ph.D

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.