The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, . including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
In cases of bone defect in proximal humerus.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

Device Description

The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup that is joined to the humeral stem. The RSP Monoblock stem includes a humeral stem with socket attached, and humeral socket insert. This change is to replace the current titanium plasma spray coating with porous coating on the size 6 stem only. There are no changes to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Reverse® Shoulder Prosthesis Monoblock). It does not describe a study conducted to demonstrate that a device meets specific acceptance criteria based on its performance in assessing or diagnosing conditions. Instead, this document is focused on demonstrating that a physical implant is substantially equivalent to previously marketed devices.

Therefore, most of the requested information (related to device performance in a diagnostic or assessment context, such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.

However, I can extract information regarding non-clinical testing which serves as the "study" demonstrating the device meets performance criteria for a physical implant.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing performed to ensure the updated device (specifically, the change from titanium plasma spray coating to porous coating on the size 6 stem) remains substantially equivalent to its predicates. The acceptance criteria are implicitly met if the test results are comparable to the predicate devices and demonstrate satisfactory performance for the intended use of the implant.

Acceptance Criteria (Implied by testing)	Reported Device Performance
Sufficient fatigue resistance	Testing determined device is substantially equivalent to predicates.
Adequate coating shear strength	Testing determined device is substantially equivalent to predicates.
Adequate coating tensile strength	Testing determined device is substantially equivalent to predicates.
Appropriate bead size	Testing determined device is substantially equivalent to predicates.
Appropriate pore size	Testing determined device is substantially equivalent to predicates.
Satisfactory porosity	Testing determined device is substantially equivalent to predicates.
Adequate bead layer	Testing determined device is substantially equivalent to predicates.
Sufficient coating thickness	Testing determined device is substantially equivalent to predicates.

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

Sample Size: Not specified in terms of number of physical devices or tests conducted for each parameter. The document generally states "All testing."
Data Provenance: The testing was non-clinical (laboratory-based) and conducted by the manufacturer, DJO Surgical, in preparation for the 510(k) submission. Therefore, it is prospective in the context of the submission. The country of origin of the data would be the location where DJO Surgical conducted its testing (implicitly, the United States, given the address included).

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

Not applicable. This device is a physical implant, and the "ground truth" for its performance is established through engineering and biomechanical testing standards, not expert medical opinion on a dataset.

4. Adjudication Method for the Test Set:

Not applicable. This testing involves objective measurements against engineering specifications and comparison to predicate device performance, not subjective review requiring adjudication.

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

No. This is a 510(k) submission for a physical implant, not an AI/diagnostic device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering specifications, industry standards, and the performance characteristics of predicate devices that have been previously deemed safe and effective. The non-clinical tests verify that the modified device meets these established performance benchmarks.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

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

November 2, 2016

Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K140904

Trade/Device Name: Reverse® Shoulder Prosthesis Monoblock Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: April 9, 2014 Received: April 9, 2014

Dear Ms. Hutto:

This letter corrects our substantially equivalent letter of May 6, 2014.

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 (reporting of medical

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Page 2 - Ms. Teffany Hutto

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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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K140904

K140904 510(k) Number (ifknown): ________

Device Name: Reverse Shoulder Prosthesis Monoblock

Indications for Use:

Reverse® Shoulder Prosthesis Monoblock Indications for Use

In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the . shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
In cases of bone defect in proximal humerus. ●

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

000063

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MAY 0 6 2014

K140904

510(k) Summary

Date: April 9, 2014

Manufacturer:

DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com

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Description:

Indications for Use:

In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, . including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
In cases of bone defect in proximal humerus.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

Predicate Devices: RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis - DJO Surgical K041066

Comparable Features to Predicate Device is comparable to the current RSP Monoblock Stem in indications, material, dimensions, surgical implantation technique, and intended use. This device will have the same porous coating as cleared with the RSP Baseplate with Porous Coating. This device has the same implant packaging and sterilization as the Reverse Shoulder Prosthesis. There no features included in this change that are not already cleared in a predicate device listed above.

Non-Clinical Testing: Fatigue testing, coating shear strength, coating tensile strength, bead size measurement, pore size measurement, porosity assessment, bead layer assessment, coating thickness assessment. All testing has determined that the device is substantially equivalent to the predicated devices.

Clinical Testing: None provided.

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.”