SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM

K081016 · Smith & Nephew, Inc. · PHX · Sep 5, 2008 · Orthopedic

Device Facts

• Record ID: K081016
• Device Name: SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROMOS Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem and body components are intended for cementless use. The implants of the PROMOS Reverse Shoulder System are single use device

Device Story

Reverse shoulder prosthesis; inverted glenohumeral articulation compared to traditional total shoulder systems. Ball component attaches to glenoid baseplate; cup component attaches to humeral stem. Used in orthopedic surgery to replace shoulder joint in patients with severe rotator cuff deficiency. Relies on deltoid muscle for joint function. Implanted by orthopedic surgeons. Provides mechanical stability and restores joint function in patients where traditional anatomical replacement is unsuitable due to cuff deficiency.

Clinical Evidence

Bench testing only; mechanical data indicates components are equivalent to currently used clinical devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Reverse shoulder prosthesis; inverted ball-and-socket configuration. Glenoid baseplate (cementless, screw fixation); humeral stem and body (cementless). Single-use metallic/polymer components.

Indications for Use

Indicated for patients with grossly deficient rotator cuff joints, severe arthropathy, or failed prior joint replacements. Requires anatomically/structurally suitable joint and functional deltoid muscle. Contraindicated if rotator cuff is intact or deltoid muscle is non-functional.

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

• PLUS Orthopedics AG's PROMOS Modular System (K063578)
• Depuy Orthopedics' DELTA CTA Reverse Shoulder Prosthesis (K021478)
• Tornier S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873)
• Encore Medical Reverse Shoulder Prosthesis System (K041066)
• Zimmer's Anatomical Inverse/Reverse Shoulder (K053274)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

November 2, 2016

Smith and Nephew, Incorporated Mr. Jason Sells Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116

Re: K081016

Trade/Device Name: Smith and Nephew, Inc. PROMOS Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: August 18, 2008 Received: August 19, 2008

Dear Mr. Sells:

This letter corrects our substantially equivalent letter of September 5, 2008.

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

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Page 2 - Mr. Jason Sells

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 contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

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

Enclosure

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## Indications for Use

510(k) Number (if known): K081016

Device Name: Smith & Nephew, Inc. PROMOS Reverse Shoulder System

Indications for Use:

The PROMOS Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.

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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The humeral stem and body components are intended for cementless use.

The implants of the PROMOS Reverse Shoulder System are single use device

Mike N. Millam

(Division: Sign-Off) (Division of General, Restorative, and Neurological Devices 08/01/6

510(k) Number

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K081016

Summary of Safety and Effectiveness Smith & Nephew, Inc. PROMOS® Reverse Shoulder System

SEP - 5 2008

Date of Summary: July 14, 2008

Contact Person and Address Jason Sells Project Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T [phone]

Name of Device: Smith & Nephew, Inc. PROMOS® Reverse Shoulder System Common Name: Shoulder Prosthesis Device Classification Name and Reference: 21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Device Class: Class II Panel Code: Orthopaedics/87 HSD

### Device Description

Subject of this Traditional 510(k) premarket notification is the PROMOS Reverse Shoulder System. The glenohumeral articulation of the Promos Reverse Shoulder is inverted - when compared to traditional total shoulder prostheses. Unlike traditional fotal shoulder prostheses, the Promos Reverse Shoulder is designed so that the "ball" component of the shoulder is assembled to the glenoid baseplate and the "cup" component is assembled onto the humeral stem.

# Mechanical and Clinical Data

A review of the mechanical and clinicates that the implant components of the Promos Reverse Shoulder System are equivalent to devices currently used dinically and are capable of withstanding expected in vivo loading without failure.

### Intended Use

The PROMOS Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.

The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The glencid baseplate is intended for cementless application with the addition of screws for fixalion.

The humeral stem and body components are intended for cementless use.

The implants of the PROMOS Reverse Shoulder System are single use devices.

#### Substantial Equivalence Information

The substantial equivalence of the Promos Reverse Shoulder System is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - PLUS Orthopedics AG's PROMOS Modular System (K063578), Depuy Orthopedics' DELTA CTA Reverse Shoulder Prosthesis (K021478), the Tomier S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873), the Encore Medical Reverse Shoulder Prosthesis Syslem (K041066), and Zimmer's Anatomical Inverse/Reverse Shoulder (K053274).