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

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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Promos Modular Shoulder System. This notification focuses on modifications to the inclination set components of an already cleared device, intended to increase overall strength and stability. The submission highlights mechanical testing as the basis for demonstrating safety and effectiveness, and no clinical data or studies comparing AI to human performance were conducted as this is a device modification submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must achieve)	Reported Device Performance (How the device performed)
Mechanical Strength and Stability: Capable of withstanding expected in vivo loading without failure.	Demonstrated that the Promos Modular Shoulder System, with the modified inclination sets, is capable of withstanding expected in vivo loading without failure.
Static Testing of Set Screw: Specific criteria for set screw static strength (details not provided in the document).	Testing performed and results indicated no new issues related to safety and effectiveness.
Pre-fatigue Taper Strength: Specific criteria for taper strength before fatigue (details not provided).	Testing performed and results indicated no new issues related to safety and effectiveness.
Construct Fatigue, including Post-fatigue Taper Evaluations: Specific criteria for fatigue of the overall construct and taper integrity after fatigue (details not provided).	Testing performed and results indicated no new issues related to safety and effectiveness.

Note: The document states that "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." Specific quantitative acceptance criteria or threshold values for the mechanical tests are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size (number of units tested) for each mechanical test. It generally refers to "mechanical data" and "mechanical testing."
Data Provenance: The data is generated from retrospective mechanical testing performed on the modified Promos Modular Shoulder System components. The country of origin for the testing data is not explicitly stated but is implicitly within the scope of Smith & Nephew's internal development and testing processes, likely in the US or where their manufacturing/R&D facilities are located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. This submission is for a medical device modification based on mechanical performance, not a diagnostic or AI-driven system requiring expert assessment of a test set for ground truth. The "ground truth" here is the physical performance of the device against engineering standards.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there is no expert-adjudicated test set in the context of this 510(k) submission. Mechanical test results are interpreted against established engineering principles and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study was not conducted. This is a submission for a mechanical device modification, not a diagnostic or AI-assisted system. No human readers or AI assistance are involved in the performance evaluation described.

6. Standalone (Algorithm Only) Performance Study

No. A standalone performance study of an algorithm was not conducted. This submission pertains to a physical medical device.

7. Type of Ground Truth Used

Engineering Standards and Mechanical Properties. The ground truth for evaluating the device's performance is based on established engineering principles, material properties, and mechanical test standards (e.g., ISO 5832-3 for Ti-6Al-4V material). The "review of mechanical data" against expected in vivo loading conditions serves as the basis for determining safety and effectiveness.

8. Sample Size for the Training Set

Not Applicable. This is a mechanical device submission. There is no "training set" in the context of algorithm development. The design and manufacturing processes are iterative but do not involve machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As per point 8, there is no training set for which ground truth would need to be established.

Summary

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JAN - 5 2012 - We are smith&nephew

Submitted by:	Smith & Nephew, Inc.1450 Brooks RoadMemphis, Tennessee 38116
Date of Summary:	January 4, 2012
Contact Person:	Megan Bevill, Regulatory Affairs Project ManagerT (901) 399-5340F (901) 566-7086
Name of Device:	Promos Modular Shoulder System
Common Name:	Hemi or Total Shoulder
Device Classification Name andReference:	21 CFR 888.3690 Prosthesis, shoulder, hemi-, humeral,metallic uncemented - Class II21 CFR 888.3660 Prosthesis, shoulder, semi-constrained,metal/polymer cemented - Class II
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HSD, KWS

Device Description

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	SubmissionNumber	ClearanceDate
Smith & Nephew Orthopaedics AG(former Plus Orthopedics AG)	Promos Modular ShoulderSystem	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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge to form the head and body of the bird.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

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

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
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.”