HUMELOCK CEMENTED SHOULDER PROSTHESIS

K111097 · Fx Solutions · HSD · Nov 9, 2011 · Orthopedic

Device Facts

• Record ID: K111097
• Device Name: HUMELOCK CEMENTED SHOULDER PROSTHESIS
• Applicant: Fx Solutions
• Product Code: HSD · Orthopedic
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humelock Cemented Shoulder Prosthesis is indicated for use in 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 Humelock Cemented Shoulder Prosthesis is intended for cemented use only.

Device Story

Modular hemi-shoulder replacement system; consists of humeral stem and humeral head. Stem implanted into humerus; head attaches via male/female taper. Used by orthopedic surgeons in clinical/surgical settings. Provides joint replacement for fracture or arthritis management; restores joint function; reduces pain. Cemented fixation only.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing of modular connection stability.

Technological Characteristics

Humeral stem: Ti-6Al-4V alloy (ISO 5832-3), 6-15mm diameter, grit-blasted proximal/polished distal surface. Humeral head: Co-Cr-Mo alloy (ISO 5832-12), 39-50mm diameter, 14-19mm height, centered/offset styles. Modular taper connection. Cemented fixation.

Indications for Use

Indicated for patients requiring hemi-shoulder replacement due to proximal humeral fractures, painful/disabled joints from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, and complex cases where arthrodesis/resection are unacceptable (e.g., revision of prior implants). Intended for cemented use only.

Regulatory Classification

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.

Predicate Devices

• Acumed Modular Shoulder System (K992525)
• DePuy Global Advantage Shoulder (K992065)

Submission Summary (Full Text)

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| K111097 | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|
| 3. 510(k) Summary | |
| Prepared: | April 15, 2011 |
| 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 |
| Contact: | Jean-Jacques Martin<br>[phone]<br>www.fxsolutions.fr |
| Proprietary Name: | Humelock Cemented Shoulder Prosthesis |
| Common Name: | Hemi-Shoulder Replacement System |
| Classification Name: | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis, Class II |
| Product Codes: | HSD |
| Substantially<br>Equivalent Devices: | K992525 - Acumed Modular Shoulder System<br>K992065 - DePuy Global Advantage Shoulder |

#### Device Description:

The Humelock Cemented Shoulder Prosthesis is a hemi-shoulder prosthesis consisting of a humeral stem and a humeral head.

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 stem is cylindrical with a polished surface. The proximal portion of the humeral stem has a grit blasted surface.

The humeral stem incorporates a male taper for attachment of the humeral head.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm with heights of 14 - 19mm 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 humeral stem.

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# KIII097

#### · Intended Use / Indications:

The Humelock Cemented Shoulder Prosthesis is indicated for use in 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 Humelock Cemented Shoulder Prosthesis is intended for cemented use only.

Summary of Technologies/Substantial Equivalence:

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

Non-Clinical Testing:

Mechanical testing was conducted to demonstrate the stability of the modular connection between the modular heads and the humeral stem.

Clinical Testing:

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

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

Fx Solutions % Mr. Jean-Jacques Martin 1663 rue de Majornas 01440 Viriat France

DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV - 9 2011

Re: K111097

Trade/Device Name: Humelock Cemented Shoulder Prosthesis Regulation Number: 21 CFR 888.3690 ·Regulation Name: Shoulder joint (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: October 24, 2011 Received: October 27, 2011

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

R2

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): Kli 097

Device Name: Humelock Cemented Shoulder Prosthesis

### Indications for Use:

The Humelock Cemented Shoulder Prosthesis is indicated for use in 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 Humelock Cemented Shoulder Prosthesis is 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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Michael Wes to MXM

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(Division Sign-Oft Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111097