Advanced degeneration of the shoulder joint as a result 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 Description

The modified PROMOS® Modular Shoulder System is intended to aid in the restoration of shoulder motion and elimination of pain. This device consists of two primary components, the glenoid component and the modular humeral component. The changes to the PROMOS® Shoulder that resulted in the modified PROMOS® Shoulder and are subject of this 510(k) include:

Addition of size 3.5 humeral stem, cementless .
Addition of six humeral ball heads R21 R26, with 4 mm eccentricity .
Redesign of body and inclination set to add face gear to area between . inclination set and body
Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm .
Various labeling changes .
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper.
The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw.
The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities.
Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.

AI/ML Overview

This document describes the 510(k) Premarket Notification for the PROMOS® Modular Shoulder System. The submission focuses on modifications to an existing device, K032126. It is a traditional 510(k) and primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards and design controls rather than extensive clinical studies or acceptance criteria defined in terms of device performance metrics like sensitivity/specificity.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI/software device, because it is a submission for a physical medical device (shoulder prosthesis). Instead, the acceptance criteria are related to compliance with established standards for materials, sterility, and design controls for mechanical devices.

Acceptance Criterion	Reported Device Performance
Material Compliance: Ultra High Molecular Weight Polyethylene (UHMWPe) for glenoid component	Conforms to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms.
Material Compliance: Titanium alloy (Ti6Al4V) for cementless/cemented stems	Conforms to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
Material Compliance: Wrought cobalt-chromium-molybdenum (CoCrMo) alloy for modular humeral heads	Conforms to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy.
Sterility: Radiation sterilization	Conforms to AAMI / ANSI / ISO 11137:1994, Sterilization of health care products - Requirements for validation and routine control -radiation sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002).
Biocompatibility:	Assessed by conformance to material standards (ISO 5834-2, ISO 5832-3, ISO 5832-12). No separate biocompatibility testing mentioned beyond material standards.
Performance Testing (Bench Testing): Design verification and validation	Performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30. Specific quantitative results (e.g., fatigue strength, wear rates) are not provided in this summary but would be in the full submission.
Substantial Equivalence: To predicate device K032126 (PROMOS® Modular Shoulder System)	Conclusion states that the modified device is substantially equivalent to the predicate device with respect to indications for use/intended use, and technical characteristics based on review of design control documentation and bench testing.

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

This is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/software performance study. The data provenance refers to materials (e.g., titanium alloy, UHMWPe) and the design files, not a clinical dataset. The testing performed is bench testing (e.g., mechanical, material characterization), not a study on patient data.

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

This is not applicable. Ground truth, in the context of an AI/software device, refers to a definitive answer derived from expert review or a gold standard. For this physical device, "ground truth" relates to the specification of material properties and design requirements, which are established by engineering standards and internal design teams, not by medical experts reviewing a test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. This is a physical orthopedic implant, not an imaging analysis or diagnostic AI device. An MRMC study is designed to assess the performance of human readers, with and without AI assistance, on a set of clinical cases. This type of study is not relevant to the evaluation of a shoulder prosthesis.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating performance is based on:

Engineering Standards: Compliance of materials (UHMWPe, Ti6Al4V, CoCrMo) with recognized ISO standards (e.g., ISO 5834-2, ISO 5832-3, ISO 5832-12).
Sterilization Standards: Compliance with AAMI/ANSI/ISO 11137 for radiation sterilization.
Design Controls: Verification and validation activities performed as per FDA's Design Control Requirements (21 CFR Part 820.30), which would involve testing against predefined engineering specifications and functional requirements.
Predicate Device Comparison: Establishing substantial equivalence by comparing technical characteristics and indications for use to the legally marketed predicate device (K032126).

8. The Sample Size for the Training Set

This is not applicable. There is no AI/machine learning algorithm involved that would require a "training set."

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

This is not applicable for the reasons stated above.

In summary:

This 510(k) submission is for modifications to a physical orthopedic implant. The "acceptance criteria" and "studies" are focused on demonstrating manufacturing quality, material compatibility, and engineering performance through adherence to recognized standards and bench testing, rather than clinical performance metrics typically associated with AI or diagnostic devices. The core of the submission relies on establishing substantial equivalence to a previously cleared predicate device based on these engineering and material considerations.

Summary

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063578

D.0 Premarket Notification 510(k) Summary

D.1 Submitter Information

MAR 0 2 2007

Company Name and Address:

PLUS ORTHOPEDICS AG Erlenstraße 4a CH-6343 Rotkreuz Switzerland

Contact Name:

Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056

Telephone: 508-528-1745 Facsimile: 978-752-1225 E-mail: pamela.weagraff(@quintiles.com

Date Prepared: November 27, 2006

D.2 Name of Device

2.1 Trade Name: PROMOS® Modular Shoulder System
2.2 Common Name: Hemi- or total shoulder
Classification Name and Reference: 2.3

Title 21 Code of Federal Regulation (CFR), Part 888.3690, prosthesis, shoulder, hemi-, humeral, metallic uncemented Title 21, CFR, Part 888.3660, prosthesis, shoulder, semi-constrained, metal/polymer cemented

E.3 Substantial Equivalence Claimed to Predicate Device

PROMOS® Modular Shoulder System, K032126 3.1

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Device Description E.4

Addition of size 3.5 humeral stem, cementless .
Addition of six humeral ball heads R21 R26, with 4 mm eccentricity .
Redesign of body and inclination set to add face gear to area between . inclination set and body
Addition of three Monoblock stems, cementless, size 02/30, 35 and 40 mm .
Various labeling changes .

The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe) according to ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms. The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.

The modular humeral component consists of a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross-sectional shape, previously available in seven cemented and seven cementless sizes, and now available in seven cemented and eight cementless sizes. It is attached to the body via a Morse type taper.

The cementless and cemented stems are fabricated from titanium alloy (Ti6Al4V) according to ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

The body is made of same titanium alloy as the distal stems and is available in three sizes. The body and inclination set have been redesigned to add a face gear to the area between the inclination set and body. As before the modified inclination set consists of three components: an inclination insert, an offset module, and a ball head screw.

The modular humeral heads are manufactured from wrought cobalt-chromiummolybdenum (CoCrMo) alloy according to ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy, previously available in eight different sizes/eccentricities, and now available in 14 different sizes/eccentricities.

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Since cementless or cemented stems in size 01 may be too large for some patients, the company has developed a humeral stem, size 02. The narrow crosssection of a size 02 stem precluded a modular design, i.e., 02 size stem and a selection of bodies. As a result, the company implemented the size 02 as a Monoblock system with three different heights for body sizes 30mm, 35mm, and 40mm. The design of the cross-section is the same as mentioned above in the description of the distal stem and the stem is made of the same titanium allov. The proximal portion has also been redesigned to add face gear to the area between inclination set and body.

દર્શા Intended Use

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

E.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics

The comparison of the modified PROMOS® Modular Shoulder System was based on a review of the Design Control documentation for the design changes, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was available to the company internally, i.e., PROMOS® Modular Shoulder System, K032126. The comparison considered technical characteristics and the indications for use / intended use. Bench testing was assessed.

E.7 Performance Data

7.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for prosthesis, shoulder, hemi-, humeral, metallic uncemented or prosthesis, shoulder, semi-constrained, metal/polymer cemented. The modified PROMOS® Modular Shoulder System does conform to the following FDA recognized standards:

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7.1.1 Sterility

AAMI / ANSI / ISO 11137:1994, Sterilization of health care products - Requirements for validation and routine control -radiation sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002)

7.1.2 Biocompatibility

ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2: Moulded Forms

ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

ISO 5832-12:1996, Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy

7.1.3 Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.

E.8 Conclusion:

The information and data provided in this 510(k) Premarket Notification establish that the modified PROMOS® Modular Shoulder System is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three arms or lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Plus Orthopedics AG % Ouintiles Consulting Ms. Pamela J. Weagraff, MBA, RAC Principal Consultant 18 Bridie Lane Norfolk, MA 02056

MAR 0 2 2007

K063578 Re: Trade/Device Name: PROMOS® Modular Shoulder System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Regulatory Class: II Product Code: HSD, KWS Dated: February 2, 2007 Received: February 5, 2007

Dear Ms. Weagraff:

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 such 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); good

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark N. Milkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ODE Indications Statement

5001 510(k) Number (if known): Unknown ¥ 06 3 5 7 8

Device Name: PROMOS® Modular Shoulder System

Indications for Use:

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 �
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.

AND/OR

Prescription Use: X (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)

Mark M. Miller

Division Sign-Off Division of Genera'. Restorative, and Neurological L . vices

510(k) Number K063578

Traditional 510(k) - PROMOS® Modular Shoulder System November 27, 2006

Company Confidential Page 9 of 70

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.