HUMELOCK II CEMENTED SHOULDER SYSTEM

K123814 · Fx Solutions · KWT · Aug 13, 2013 · Orthopedic

Device Facts

• Record ID: K123814
• Device Name: HUMELOCK II CEMENTED SHOULDER SYSTEM
• Applicant: Fx Solutions
• Product Code: KWT · Orthopedic
• Decision Date: Aug 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat: 1. Proximal humeral fractures 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail). The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

Device Story

Humelock II Cemented Shoulder System is a modular total and hemi-shoulder prosthesis; components include humeral stem, humeral head, double taper connector, and glenoid component. System used in orthopedic surgery for shoulder replacement. Humeral stem (Ti-6Al-4V) connects to humeral head (Co-Cr-Mo) via double taper connector (Ti-6Al-4V). Glenoid component (UHMWPE) features two pegs for cemented fixation. Offset taper design allows head rotation relative to humeral cut surface for optimal bone coverage. Surgeon implants device to restore joint function and alleviate pain in patients with arthritis or fractures. Device relies on cemented fixation for stem and glenoid components. Clinical benefit includes joint replacement for patients with severe shoulder pathology.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including mechanical stability testing of the modular connection and characterization of UHMWPE material.

Technological Characteristics

Humeral stem: Ti-6Al-4V alloy (ISO 5832-3). Humeral head: Co-Cr-Mo alloy (ISO 5832-12). Glenoid: UHMWPE (ISO 5834-2) with tantalum radiopaque markers (ASTM F560). Modular design with double taper connector. Cemented fixation only.

Indications for Use

Indicated for patients requiring total or hemi-shoulder replacement due to proximal humeral fractures, severe pain/disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or other conditions where arthrodesis/resection are not acceptable (e.g., revision of prior implants).

Regulatory Classification

Identification

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation 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, 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).

Special Controls

*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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Fx Solutions Humelock Cemented Shoulder Prosthesis (K111097)
• DePuy Global AP Shoulder System (K060874)

Submission Summary (Full Text)

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### K123814

| 3. 510(k) Summary | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------|
| Prepared On: | December 10, 2012 |
| Applicant / Sponsor: | Fx Solutions<br>1663 rue de Majornas<br>01440 Viriat<br>France |
| Manufacturer: | Compagnie Financière & Médicale<br>13 Bd Victor Hugo<br>01000 Bourg En Bresse<br>France<br>AUG 1 3 2013 |
| Contact: | Jean-Jacques Martin<br>[phone]<br>www.fxsolutions.fr |
| Proprietary Name: | Humelock II Cemented Shoulder System |
| Common Name: | Total and Hemi-Shoulder Replacement System |
| Classification Names: | 21 CFR 888.3650: Shoulder joint metal/polymer non<br>constrained cemented prothesis, Class II |
| | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis, Class II |
| Product Codes: | KWT, HSD |
| Substantially<br>Equivalent Devices: | K111097 - Fx Solutions Humelock Cemented Shoulder<br>Prosthesis |
| | K060874 - DePuy Global AP Shoulder System |

Device Description:

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stern, a humeral head, a double taper connector and, when used for total shoulder replacement, a glenoid component.

The humeral stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The distal end of the humeral stern is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.

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#### K123814

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 alloy 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 is used to connect the humeral head to the humeral stem. An impactor / extractor hole is incorporated into the proximal end of the taper.

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 glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, large and extra large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

#### Intended Use / Indications:

The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

- 1. Proximal humeral fractures
- 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

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#### Summary of Technologies/Substantial Equivalence:

Substantial equivalence of the Humelock II Cemented 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 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 UHMWPE used to manufacture the glenoids.

#### Clinical Testing:

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

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

August 13, 2013

Mr. Jean-Jacques Martin Managing Director Fx Solutions 1663 rue de Majornas Viriat, 014440 France

Re: K123814

Trade/Device Name: Humelock II Cemented Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, HSD Dated: July 1, 2013 Received: July 2, 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 does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (QS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Erin 阿狄eith

For

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

Enclosure

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#### 2. Indications for Use

510(k) Number (if known): _K123814_

Device Name: Humclock II Cemented Shoulder System

#### Indications for Use:

The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

- 1. Proximal humeral fractures
- 2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
- 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (c.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

Prescription Use -- X --(Part 21 CFR 801 Subpart D)

,

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

(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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## Elizabeth 断房rânk -S

Division of Orthopedic Devices

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