SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS

{0}------------------------------------------------ 510k Summary Summary of Safety and Effectiveness Shoulder System Instruments Smith & Nephew, Inc. K121714 (1 of 3) SFP 2012 Contact Person and Address Bradley Heil Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Memphis, Tennessee 38016 Tel: (901) 399-6339 Date of Summary: September 7; 2012 Name of Device: Shoulder System Instruments Common Name: Orthopaedic Surgical Instrumentation Device Classification Name and Reference: 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Device Class: Class II Panel Code: Orthopaedics/87 Predicate Devices: Cofield Shoulder System cemented (KI955767); Cofield Shoulder System (K855183); Cofield Modular Shoulder System (K955767); Cofield Eccentric and Lateral offset Humeral Heads (K003566); PROMOS Shoulder (K032126); PLUS PROMOS Modular Shoulder System (K063578); Cofield2 Total Shoulder System (K070565); PROMOS Reverse Shoulder System (K081016) ### Device Description Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Shoulder System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use. Smith & Nephew Shoulder System Instruments can be organized into instrument families which are categorized as follows: Trials, Guides, Insertion, Holding, Impactors, and Cutting Instruments. ### Intended Use / Indications for Use Smith & Nephew Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use. Cofield Shoulder Systems Proximal Humeral Prosthesis {1}------------------------------------------------ Summary of Safety and Effectiveness Shoulder System Instruments Smith & Nephew, Inc. - 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or head-splitting, or head impression fractures). - 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. - Avascular necrosis with intact glenoid cartilage. 3. - Selected patients with arthritis who do not have adequate scapular bone to support a 4. glenoid component or who must engage in moderately heavy activities. ### Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The Cofield Shoulder System contains devices which are intended only for use only with bone cement and are single use devices. ### Cofield2 Shoulder System Proximal Humeral Prosthesis - Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three 1. and four-part injuries in the Neer classification, or head-splitting, or head impression fractures). - 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. - 3. Avascular necrosis with intact glenoid cartilage. - 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. ### Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures The Cofield2 Shoulder System includes humeral devices which are intended for use with or without bone cement and are single use devices. Cofield' Shoulder System glenoid components are intended for use only with bone cement and are single use devices. ### PROMOS Shoulder Systems {2}------------------------------------------------ ### Summary of Safety and Effectiveness Shoulder System Instruments Smith & Nephew, Inc. ### Indications for the PROMOS Modular Shoulder System (Standard) - Advanced wear of the shoulder joint due to 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 stem and body components are intended for cementless use. The glenoid component is for use with bone cement only. ### Indications for the PROMOS Modular Shoulder System (Reverse) - . The PROMOS Reverse Shoulder 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 humeral stem and body components are intended for cementless use. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. ### Substantial Equivalence Information The device specific instruments associated with the implant devices with which they are used are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments: - Share the same raw materials; . - Are manufactured though the same processes; . - Utilize the same sterilization procedures; and . - Have similar nature of body contact . The Smith and Nephew Shoulder System Instruments are similar in design and function to competing shoulder surgical instrumentation on the market. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Smith & Nephew, Incorporated % Mr. Bradley Heil Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116 SEP 7 2012 Re: K121714 Trade/Device Name: Smith & Nephew Incorporated Shoulder System Instruments Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. HSD Dated: June 8, 2012 Received: June 11, 2012 Dear Mr. Heil: 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. 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 orice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {4}------------------------------------------------ ## Page 2 - Mr. Bradley Heil 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthonedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Device Name: Cofield2 Shoulder Systems Indications for Use: Smith & Nephew Cofield2 Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cofield® Shoulder Systems and their cleared Indications for Use. ### Indications for Shoulder Replacement Proximal Humeral Prosthesis - Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three 1. and four-part injuries in the Neer classification, or head-splitting, or head impression fractures). - 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. - 3. Avascular necrosis with intact glenoid cartilage. - 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. ### Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures The Cofield² Shoulder System includes humeral devices which are intended for use with or without bone cement and are single use devices. Cofield' Shoulder System glenoid components are intended for use only with bone cement and are single use devices. | Prescription Use | X | AND/OR | Over-The-Counter Use | |-----------------------------|---|--------|------------------------| | (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number: K121734 Page ______ of ______ {6}------------------------------------------------ ## K12171412/3 ### Indications for Use 510(k) Number (if known): Device Name: Cofield Shoulder Systems Indications for Use: . Smith & Nephew Cofield Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cofield Shoulder Systems and their cleared Indications for Use. ### Indications for Shoulder Replacement Proximal Humeral Prosthesis - Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part 1. injuries in the Neer classification, or head-splitting, or head impression fractures). - 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. - 3. Avascular necrosis with intact glenoid cartilage. - 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. ### Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures The Cofield Shoulder System contains devices which are intended only for use with bone cement and are single use devices. | Prescription Use | X | AND/OR | Over-The-Counter Use | | |-----------------------------|---|--------|------------------------|--| | (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Concurrence of Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices | 510(k) Number | 4121714 | |---------------|---------| | Page | of | {7}------------------------------------------------ # K121714(3/37 ### Indications for Use 510(k) Number (if known): Device Name: PROMOS Shoulder Systems Indications for Use: Smith & Nephew Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use. The PROMOS Modular Shoulder System (Standard) is indicated for: - Advanced wear of the shoulder joint due to degenerative, post-traumatic or inflammatory . arthritis - Avascular necrosis of the humeral head . - . Complex fractures of the proximal humerus - Functional impairment espedally in the case of post-traumatic loss of the joint configuration The humeral stem and body components are intended for cementless use. The glenoid component is for use with bone cement only. The PROMOS Modular Shoulder System (Reverse) is indicated for the following: - The PROMOS Reverse Shoulder 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 - t 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 humeral stem and body components are intended for cementless use. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. Prescription Use × AND/OR (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) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | Page ___ of ___ | |-----------------------------------------------------------|-----------------| | Division of Surgical, Orthopedic, and Restorative Devices | | | 510(k) Number | K121714 |