AltiVate® Anatomic Shoulder AG e+™ with Markers

K222592 · Encore Medical L.P. · KWS · Jun 23, 2023 · Orthopedic

Device Facts

• Record ID: K222592
• Device Name: AltiVate® Anatomic Shoulder AG e+™ with Markers
• Applicant: Encore Medical L.P.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 23, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 or uncemented applications. Glenoid components are indicated for cemented use only.

Device Story

AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge) is a glenoid component for total shoulder arthroplasty; manufactured from vitamin E-stabilized ultra-high molecular weight polyethylene (UHMWPE). Device features spherical back surface with four fixation pegs; central peg includes three annular barbs; peripheral pegs include machined 'Tri-lobe' fixation features and radiographic markers. Articulating surface radius of curvature exceeds compatible humeral heads to facilitate superior/inferior and anterior/posterior translation. Used by orthopedic surgeons in clinical settings to replace natural glenoid surface; provides immediate fixation to patient bone. Benefits include pain relief and restoration of shoulder function in patients with degenerative or inflammatory joint disease.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by bench testing, including dynamic evaluation of glenoid loosening per ASTM F2028-17 and endotoxin assessment via Kinetic Chromogenic method.

Technological Characteristics

Material: Vitamin E-stabilized UHMWPE. Design: Glenoid component with spherical back, four fixation pegs (central with barbs, peripheral with Tri-lobes), and radiographic markers. Articulation: Radius of curvature allows translation. Fixation: Cemented. Testing: ASTM F2028-17 for glenoid loosening.

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 of prior devices 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 Shoulder AG e+™ with Markers (K213387)
• Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids (K103419, K111379, K121220)

Submission Summary (Full Text)

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June 23, 2023

Encore Medical, L.P Michael Siano Sr. Program Manager, RA 9800 Metric Blvd Austin, Texas 78758

Re: K222592

Trade/Device Name: AltiVate® Anatomic Shoulder AG e+™ with Markers Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder ioint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. PAO Dated: June 20, 2023 Received: June 20, 2023

Dear Michael 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

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

Sincerely,
Joseph P. Russell Digitally signed by Joseph P.
Russell -S
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Date: 2023.06.23 10:20:00 -04'00'
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For: Farzana Sharmin, Ph.D. 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

Submission Number (if known)

K222592

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 or uncemented 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)

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Image /page/3/Picture/0 description: The image shows the logo for Enovis. The word "enovis" is written in a stylized font, with the "eno" in red and the "vis" in black. There is a gray and black graphic between the "o" and the "v". The letters "TM" are in the bottom right corner of the logo.

## 510(k) Summary

### I. SUBMITTER

Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758

Phone: [phone] Fax: [phone]

Contact Person: Michael A. Siano, Sr. Program Manager, RA Date Prepared: June 21, 2023

II. DEVICE

Name of Device: AltiVate® Anatomic Shoulder AG e+™ with Markers Common 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 DEVICES

Primary Predicate: Encore Medical, L.P., AltiVate® Anatomic Shoulder AG e+™ with Markers, K213387

Additional Predicate: Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids [K103419 (8°)/K111379 (12°)// K121220 (16°)]

### IV. DEVICE DESCRIPTION

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), 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:

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- . 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 or uncemented applications. Glenoid components are indicated for cemented use only.

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

Enovis has demonstrated substantial equivalence to the half-wedge model from the same product family—the AltiVate® Anatomic Shoulder AG e+™ with Markers (K213387). The subject and primary predicate are identical in almost all aspects, including indications for use, manufacturing, sterilization, packaging, materials and contact materials.

### Endotoxin Assessment

Enovis 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 was performed per ASTM F2028-17.

### Animal Study

No animal studies were undertaken.

## Clinical Studies

Clinical data was not required.

### VIII. CONCLUSIONS

All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate devices identified.