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.

Indications for Shoulder Replacement:
Proximal Humeral Prosthesis

Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three and four-part injuries in the Neer classification, or head-splitting, or head impression fractures).
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.
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

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

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.

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.

AI/ML Overview

This 510(k) summary for the Smith & Nephew Shoulder System Instruments does not contain information regarding acceptance criteria or a study proving the device meets those criteria. The document is a premarket notification for surgical instruments, and its primary purpose is to establish substantial equivalence to predicate devices, not clinical performance for the instruments themselves.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and studies as they are not present in the provided text.

Based on the content analysis, here's what can be inferred about why this information is missing and what the document does address:

Device Type: The "Smith & Nephew Shoulder System Instruments" are described as "accessory devices" intended to "assist in the implantation" of other cleared Smith & Nephew Shoulder Systems. They are not the implantable devices themselves, but rather the tools used during surgery.
Regulatory Pathway: This is a Traditional 510(k) Premarket Notification. For accessory devices or instruments that are largely mechanical and support the use of already cleared implantable devices, the FDA typically focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices.
Substantial Equivalence Justification: The document explicitly states the basis for substantial equivalence (Page 3):
- Share the same raw materials.
- Are manufactured through the same processes.
- Utilize the same sterilization procedures.
- Have similar nature of body contact.
  It further asserts that "The Smith and Nephew Shoulder System Instruments are similar in design and function to competing shoulder surgical instrumentation on the market."

Missing Information:

Since this document is a 510(k) for surgical instruments demonstrating substantial equivalence, it does not typically include:

Acceptance Criteria Table & Performance Results: These are usually for implantable devices or diagnostics where clinical performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength against specific standards) are directly relevant. For instruments, the "performance" is inherently linked to their ability to facilitate the implantation of the main device, and this is typically assumed if they are substantially equivalent to existing instruments.
Sample Size for Test Set, Data Provenance, Expert Ground Truth, Adjudication Methods: These details are specific to clinical studies or performance testing, which are generally not required for basic surgical instruments under a substantial equivalence pathway.
MRMC Comparative Effectiveness Study: This is for evaluating changes in human reader performance with AI assistance, which is entirely irrelevant to surgical tools.
Standalone (Algorithm Only) Performance: Also irrelevant, as these are physical instruments, not an algorithm.
Type of Ground Truth: Not applicable, as there's no diagnostic output or measurement being made by the instruments themselves that would require a ground truth.
Training Set Sample Size & Ground Truth: These are related to machine learning models, which are not involved here.

In summary, the provided document focuses on demonstrating that the manufacturing process, materials, and intended function of these new surgical instruments are similar enough to existing, legally marketed instruments that they do not raise new questions of safety and effectiveness. Clinical performance studies with explicit acceptance criteria are not typically part of this specific regulatory submission type for this class of device.

Summary

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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

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

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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).
1. 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).
1. 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.
1. Avascular necrosis with intact glenoid cartilage.
1. 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

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.

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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

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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

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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).
1. 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.
1. Avascular necrosis with intact glenoid cartilage.
1. 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

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 ______

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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).
1. 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.
1. Avascular necrosis with intact glenoid cartilage.
1. 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

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

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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

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
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.(b)
Classification. Class II.