The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.

The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.

Device Description

The AltiVate Anatomic Canal-Sparing (CS) Shoulder is a canal-sparing prothesis intended for use in an anatomic Total Shoulder Arthroplasty (aTSA) application. The canal-sparing prosthesis is a modular humeral component consisting of a metaphyseal humeral stem and humeral neck that are compatible with previously cleared DJO humeral heads and DJO keeled and pegged glenoids.

AltiVate Anatomic CS Humeral Stem -
The AltiVate Anatomic CS Humeral Stem component (Ti-6Al-4V per ASTM F1472) is a 3-fin design that extend radially from the central body and are equally spaced at 120°. It has a female Morse taper to accept the humeral neck component. The stem is tapered and has one consistent collar diameter. It has porous coating applied around the outer central body, fins, and bottom of the collar for cementless fixation in the proximal humerus. The stem is offered in three sizes, ranging from 18mm to 24mm in length.

AltiVate Anatomic CS Humeral Neck -
The AltiVate Anatomic CS Humeral Neck component (CoCr per ASTM F1537) is a dual Morse taper and is the modular connection between the humeral stem and the humeral head and is offered in one neutral size.

AI/ML Overview

This document describes a 510(k) premarket notification for the AltiVate® Anatomic Canal-Sparing (CS) Shoulder system. Based on the provided text, there was no clinical study performed or required for this device to prove it meets acceptance criteria. The submission relies solely on non-clinical testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested details regarding acceptance criteria and study methodology cannot be filled from the provided text.

Here is a breakdown of what can and cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document states: "Non-clinical testing has demonstrated the device's ability to perform under expected conditions." and "All testing has determined that the device is substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., "pull-out strength must be > X N") and the exact reported performance values from these non-clinical tests are not detailed in the provided text. The document lists the types of non-clinical tests performed:

Test Type	Reported Device Performance (as described in document)
Taper Disassociation Testing	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Humeral Construct Fatigue Testing	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Torque-Out Testing	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Axial Pull-Out Testing	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Humeral Micromotion - Cadaveric Experimental Analysis	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Humeral Micromotion - Finite Element Analysis (FEA)	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Humeral Fit Analysis	Demonstrated ability to perform under expected conditions; substantially equivalent to predicate devices.
Endotoxin Assessment	Pyrogen limit specifications are met via the Kinetic Chromogenic method.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the non-clinical tests (e.g., how many cadaveric humeri were used, how many fatigue cycles were performed).
Data Provenance: Not specified. This would typically refer to the origin of the test materials (e.g., cadaveric specimens from a specific tissue bank) or the location of the testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this was a non-clinical evaluation, not a clinical study requiring expert ground truth establishment for patient data.

4. Adjudication method for the test set:

Not applicable due to the nature of the non-clinical testing.

5. 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:

No MRMC or any clinical study was done. The device is a physical shoulder implant, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For physical mechanical tests, the "ground truth" is typically the measured physical properties and performance against predefined engineering specifications or predicate device performance. For the cadaveric analysis, the 'ground truth' would be the direct physical measurement outcomes from those experiments.

8. The sample size for the training set:

Not applicable. There was no clinical study, and thus no "training set" in the context of machine learning or clinical data analysis.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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June 3, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K193226

Trade/Device Name: AltiVate® Anatomic Canal-Sparing (CS) Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: April 30, 2020 Received: May 1, 2020

Dear Teffany Hutto:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K193226

Device Name

AltiVate® Anatomic Canal-Sparing (CS) Shoulder

Indications for Use (Describe)

The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.

The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Date: May 28, 2020

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: (760) 597-3466 Email: teffany.hutto@djoglobal.com

Product	Common Name	Classification	Product Code
AltiVate® AnatomicCanal-Sparing (CS) Shoulder	Total Shoulder Implant	Class II	PKC

Product Code	Regulation and Classification Name
PKC	Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR 888.3660

Description:

AltiVate Anatomic CS Humeral Stem -

The AltiVate Anatomic CS Humeral Stem component (Ti-6Al-4V per ASTM F1472) is a 3-fin design that extend radially from the central body and are equally spaced at 120°. It has a female Morse taper to accept the humeral neck component. The stem is tapered and has one consistent collar diameter. It has porous coating applied around the outer central body, fins, and bottom of the collar for cementless fixation in the proximal humerus. The stem is offered in three sizes, ranging from 18mm to 24mm in length.

AltiVate Anatomic CS Humeral Neck -

The AltiVate Anatomic CS Humeral Neck component (CoCr per ASTM F1537) is a dual Morse taper and is the modular connection between the humeral stem and the humeral head and is offered in one neutral size.

Indications for Use:

The AltiVate Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.

The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.

Predicate Devices:

Device	Manufacturer	510(k) Number
Simpliciti Shoulder System	Tornier	K143552
AltiVate Anatomic Shoulder System	Encore Medical, L.P.	K162024

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Comparable Features to Predicate Device(s):

Intended Use and Indications for Use ●
Material (Stem and Neck) ●
Porous Coating ●
Bone Fixation
Quantity of Fins
Size Offerings ●
. Length Offerings

Key Differences in Subject Device to Predicate:

. Fin width of subject device increases incrementally
Collar diameter is smaller than predicate

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

Taper Disassociation Testing
Humeral Construct Fatigue Testing
Torque-Out Testing
Axial Pull-Out Testing
Humeral Micromotion - Cadaveric Experimental Analysis
Humeral Micromotion - Finite Element Analysis (FEA)
Humeral Fit Analysis o

All testing has determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.

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.”