PROMOS MODULAR SHOULDER SYSTEM

K113012 · Smith & Nephew, Inc. · KWS · Jan 5, 2012 · Orthopedic

Device Facts

• Record ID: K113012
• Device Name: PROMOS MODULAR SHOULDER SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jan 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Promos Modular Shoulder System is indicated for: - Advanced degeneration of the shoulder joint as a results of degenerative, post-traumatic or . inflammatory arthritis - Avascular necrosis of the humeral head . - . Complex fractures of the proximal humerus - Functional impairment especially in the case of post-traumatic loss of the joint configuration . The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.

Device Story

Promos Modular Shoulder System is a modular shoulder prosthesis consisting of a glenoid component and a modular humeral component (distal stem, body, inclination set, humeral head). This submission modifies the inclination set (internal cone, sleeve, set screw) to improve construct strength and stability. The device is implanted by orthopedic surgeons in a clinical/surgical setting to replace or reconstruct the shoulder joint. The system provides structural support and joint articulation for patients with degenerative or traumatic shoulder conditions. The humeral component is designed for cementless fixation, while the glenoid component requires bone cement. The modification maintains the original design concept and mating interfaces with existing humeral head and body components.

Clinical Evidence

Bench testing only. Mechanical testing included static testing of the set screw, pre-fatigue taper strength, and construct fatigue testing (including post-fatigue taper evaluations). No clinical data was required.

Technological Characteristics

Modular shoulder prosthesis components. Inclination set components (internal cone, sleeve, set screw) manufactured from Ti-6Al-4V (ISO 5832-3). Humeral component designed for cementless use; glenoid component for cemented use. Mechanical testing performed to verify structural integrity under in vivo loading conditions.

Indications for Use

Indicated for patients with advanced shoulder joint degeneration (degenerative, post-traumatic, or inflammatory arthritis), avascular necrosis of the humeral head, complex proximal humerus fractures, or functional impairment due to post-traumatic joint configuration loss.

Regulatory Classification

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).

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 “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.”

Predicate Devices

• Promos Modular Shoulder System (K063578)
• Cofield 2 Shoulder System (K955767)

Submission Summary (Full Text)

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JAN - 5 2012 - We are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>1450 Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 4, 2012 |
| Contact Person: | Megan Bevill, Regulatory Affairs Project Manager<br>T [phone]<br>F [phone] |
| Name of Device: | Promos Modular Shoulder System |
| Common Name: | Hemi or Total Shoulder |
| Device Classification Name and<br>Reference: | 21 CFR 888.3690 Prosthesis, shoulder, hemi-, humeral,<br>metallic uncemented - Class II<br>21 CFR 888.3660 Prosthesis, shoulder, semi-constrained,<br>metal/polymer cemented - Class II |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSD, KWS |

### Device Description

The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.

The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.

#### Technological Characteristics

A review of the mechanical data indicates that the Promos Modular Shoulder System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Promos Modular Shoulder System was performed:

- Static testing of set screw .
- . Pre-fatigue taper strength
- Construct fatigue, including post-fatigue taper evaluations �

A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

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### Intended Use

The Promos Modular Shoulder System is indicated for:

- Advanced degeneration of the shoulder joint as a results of degenerative, post-traumatic or . inflammatory arthritis
- Avascular necrosis of the humeral head .
- . Complex fractures of the proximal humerus
- Functional impairment especially in the case of post-traumatic loss of the joint configuration .

The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.

# Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material m ourition, and very similar in overall design to the Promos Modular Shoulder System Inclination Sets cleared via premarket notification K063578. They are also similar in intended use to the Cofield 2 Shoulder System cleared via premarket notification K955767.

#### Table 1: Substantially equivalent predicate devices

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|----------------------------------------------------------------|-----------------------------------|----------------------|-------------------|
| Smith & Nephew Orthopaedics AG<br>(former Plus Orthopedics AG) | Promos Modular Shoulder<br>System | K063578 | 3/2/2007 |
| Smith & Nephew, Inc. | Cofield 2 Shoulder System | K955767 | 4/8/1996 |

#### Conclusion

As neeviously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified Inclination Sets of the Promos Modular Shoulder System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate shoulder system.

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

JAN - 5 2012

Smith & Nephew, Incorporated % Ms. Megan Bevill Regulatory Affairs Project Manager 1450 Brooks Road Memphis Tennessee 38116

Re: K113012

Trade/Device Name: Promos Modular Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: October 7, 2011 Received: October 11, 2011

Dear Ms. Bevill:

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. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ーーーーー

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

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# Page 2 - Ms. Megan Bevill

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm

Sincerely yours,

Sincerely yours,

for

Mark N. Melkerson

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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# Indications for Use

510(k) Number (if known):

Device Name: Promos Modular Shoulder System

The Promos Modular Shoulder System is indicated for:

- Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or . inflammatory arthritis '
- Avascular necrosis of the humeral head o
- Complex fractures of the proximal humerus �
- Complex freetarse of the precially in the case of post-traumatic loss of the joint configuration .

The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

BBhach

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113012