AltiVate® Anatomic Shoulder AG e+™ with Markers

K213387 · Encore Medical L.P. · KWS · Jul 7, 2022 · Orthopedic

Device Facts

• Record ID: K213387
• Device Name: AltiVate® Anatomic Shoulder AG e+™ with Markers
• Applicant: Encore Medical L.P.
• Product Code: KWS · Orthopedic
• Decision Date: Jul 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis • Rheumatoid and other inflammatory arthritis • Correction of functional deformity, including fracture malunion • Humeral head fracture • Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

Device Story

The AltiVate® Anatomic Shoulder AG e+™ with Markers is a glenoid component for total shoulder arthroplasty. It is manufactured from ultra-high molecular weight polyethylene (UHMWPE) infused with vitamin E. The device features a spherical back surface with four pegs for cemented fixation: a central peg with annular barbs and three peripheral pegs with Tri-lobe fixation features. Radiographic markers are embedded in the peripheral pegs to assist surgeons in post-operative visualization. The articulating surface is designed with a radius of curvature larger than the humeral head to facilitate superior/inferior and anterior/posterior translation. The device is implanted by orthopedic surgeons in a clinical/hospital setting to replace the natural glenoid, aiming to restore joint function and alleviate pain in patients with degenerative or inflammatory shoulder conditions.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through bench testing, including dynamic evaluation of glenoid loosening or disassociation performed per ASTM F2028-17 and endotoxin assessment via the Kinetic Chromogenic method.

Technological Characteristics

Material: Vitamin E-infused ultra-high molecular weight polyethylene (UHMWPE). Design: Semi-constrained glenoid component with spherical back surface and four-peg fixation (central barbed peg, peripheral Tri-lobe pegs). Radiographic markers included in peripheral pegs. Fixation: Cemented. Testing standards: ASTM F2028-17 for dynamic glenoid evaluation. Sterilization: Not specified.

Indications for Use

Indicated for patients with shoulder pain and dysfunction due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, post-traumatic arthritis), rheumatoid/inflammatory arthritis, functional deformity (fracture malunion), humeral head fracture, or revision cases with sufficient bone stock.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• AltiVate Anatomic Pegged Glenoid with Markers (K203026)
• AltiVate Anatomic Shoulder (K162024)

Reference Devices

• Aequalis PerFORM+ Shoulder System (K150583)
• Total Shoulder Prosthesis (K950651)

Submission Summary (Full Text)

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July 7, 2022

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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Encore Medical, L.P. Michael A. Siano Senior Program Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

## Re: K213387

Trade/Device Name: AltiVate® Anatomic Shoulder AG e+™ with Markers Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, PAO Dated: June 2, 2022 Received: June 6, 2022

Dear Michael A. Siano:

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 (QS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Jiping Chen, M.D., Ph.D., M.P.H. Acting Division 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

510(k) Number (if known)

#### K213387

Device Name

AltiVate® Anatomic Shoulder AG e+TM with Markers

Indications for Use (Describe)

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

· Rheumatoid and other inflammatory arthritis

- · Correction of functional deformity, including fracture malunion
- · Humeral head fracture
- · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the DJO Surgical logo. The logo consists of a red circle on the left, followed by the letters "DJO" in black. To the right of "DJO" is the word "SURGICAL" in a smaller, lighter font. The logo is simple and modern, and the use of red and black gives it a bold and professional look.

## 510(k) Summary

#### I. SUBMITTER

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

Phone: [phone] Fax: [phone]

Contact Person: Michael A. Siano, Sr. Program Manager, RA Date Prepared: October 13, 2021

#### II. DEVICE

Name of Device: AltiVate® Anatomic Shoulder AG e+™ with Markers Common or Usual Name: Total Shoulder Implant Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis (888.3660) Regulatory Class: II Product Code(s): KWS, PAO

#### III. PREDICATE DEVICE

Encore Medical, L.P., AltiVate Anatomic Pegged Glenoid with Markers, K203026 (Primary Predicate) Encore Medical, L.P., AltiVate Anatomic Shoulder, K162024

Reference devices: Tornier, Inc., Aequalis PerFORM+ Shoulder System, K150583 Encore Orthopedics, Inc., Total Shoulder Prosthesis, K950651

### IV. DEVICE DESCRIPTION

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

### V. INDICATIONS FOR USE

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

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Image /page/4/Picture/1 description: The image shows the logo for DJO Surgical. The logo consists of a red circle with a white design inside, followed by the text "DJO" in black, and then the word "SURGICAL" in a smaller, lighter font. The logo is clean and professional, suggesting a company in the medical or surgical field.

- . Rheumatoid and other inflammatory arthritis
- . Correction of functional deformity, including fracture malunion
- . Humeral head fracture
- . Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Comparable Elements to Predicate Device(s):

Different Elements to Predicate Device(s):

- Intended Use and Indications for Use ●
- Augmented back surface geometry

- Material
.

- Articulating surface geometry
- . Size Offerings
- Radiographic markers
- Sterilization

Any noted differences do not raise different questions of safety and effectiveness.

### Endotoxin Assessment

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

### Mechanical and acoustic testing

Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17.

### Animal Study

No animal studies were undertaken.

### Clinical Studies

Clinical data was not required.

### VII. CONCLUSIONS

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