REVERSE SHOULDER PROSTHESIS by DJO SURGICAL

For treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

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

Device Description

The modification consists of an addition of a size 44mm glenoid head and size 44mm humeral poly socket. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to materials, design, or method of manufacture.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Reverse® Shoulder Prosthesis." It describes a modification to an existing device, specifically the addition of a size 44mm glenoid head and a size 44mm humeral poly socket.

Based on the provided text, there is no acceptance criteria or study that proves the device meets acceptance criteria in the traditional sense of an AI/ML device evaluating performance against specific metrics. This document is for a mechanical medical device (a prosthetic joint), and the submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the structure provided in your prompt, highlighting why many sections are not applicable to this type of device submission:

A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not establish performance criteria in terms of accuracy, sensitivity, specificity, etc., as would be done for an AI/ML device. The "performance" for this mechanical device is assessed through "Non-Clinical Testing" which demonstrated its ability "to perform under expected clinical conditions."
- The submission is for a modification, and the core claim is "no change to the intended use or fundamental scientific technology...no changes to materials, design, or method of manufacture" other than the size addition.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No human clinical "test set" data is mentioned. The "Non-Clinical Testing" likely refers to bench testing (mechanical strength, wear, etc.). The sample size for such tests would be for the number of prostheses tested, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" establishment in the context of diagnostic interpretation or algorithmic output for this mechanical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human interpretation or adjudication of a test set is discussed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical devices like this, the "ground truth" often relates to engineering specifications and material properties verified through non-clinical testing. While clinical outcomes are ultimately important, they are not part of this specific 510(k) submission to demonstrate substantial equivalence for a minor modification.
The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this mechanical device.

Summary of what is provided in the document:

Device Name: Reverse® Shoulder Prosthesis
Regulation Number/Name: 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX, KWS
Modification: Addition of a size 44mm glenoid head and size 44mm humeral poly socket.
Claim: "no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to materials, design, or method of manufacture."
Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." (No specifics on the nature or results of this testing are provided in this summary document).
Clinical Testing: "None provided."
Predicate Device: DJO Surgical Reverse Shoulder Prosthesis (K041066 & K051075)

This document is a formal communication from the FDA to the manufacturer regarding a 510(k) submission. It confirms the FDA's determination of "substantial equivalence" based on the information provided by the manufacturer. The core of this type of submission for a mechanical device modification is to show that the modified device is as safe and effective as a legally marketed predicate device, often relying heavily on non-clinical (bench) testing rather than human clinical studies for minor changes.

Summary

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

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

November 2, 2016

DJO Surgical Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758

Re: K092873

Trade/Device Name: Reverse® Shoulder Prosthesis 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: October 16, 2009 Received: October 19, 2009

Dear Ms. Hutto:

This letter corrects our substantially equivalent letter of October 27, 2009.

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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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/ResourcesforYou/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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510(k) Number (if known): _

Device Name: Reverse Shoulder Prosthesis

Indications for Use:

Reverse® Shoulder Prosthesis Indications for Use

For treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonata 3 for mxn
Division S1200

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092873

Page 1 of 1

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K0928>3

OCT 2 7 2009

Summary of Safety and Effectiveness

Date: October 22, 2009

Manufacturer: DJO Surgical (legally 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

Product	510(k) Number, Clearance Date/ Classification	Product Code	Product Code	Regulation and Classification Name
Reverse® Shoulder Prosthesis	K041066 – March 24, 2005K051075 – May 27, 2005Class II	KWS	KWS	Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660

Description: The modification consists of an addition of a size 44mm glenoid head and size 44mm humeral poly socket. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to materials, design, or method of manufacture.

Indications for Use: The RSP is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application of screws for fixation. The humeral stem is intended for cemented use only.

Predicate Device:

· K041066 & K051075 - DJO Surgical Reverse Shoulder Prosthesis

Comparable Features to Predicato Device(s): Features comparable to predicate devices include the same indications, materials, sterilization, and intended use.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.

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.”