AltiVate Reverse® Glenoid

K252141 · Encore Medical L.P. · PHX · Aug 5, 2025 · Orthopedic

Device Facts

• Record ID: K252141
• Device Name: AltiVate Reverse® Glenoid
• Applicant: Encore Medical L.P.
• Product Code: PHX · Orthopedic
• Decision Date: Aug 5, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; Bone defect in proximal humerus; Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; Inflammatory arthritis including rheumatoid arthritis; Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

Device Story

AltiVate Reverse® Glenoid is a semi-constrained shoulder prosthesis component. This submission introduces an alternative surgical reaming technique for preparing the glenoid surface for the wedge baseplate. The device is implanted by orthopedic surgeons in a clinical/surgical setting. It functions as a reverse shoulder replacement to restore joint function and alleviate pain in patients with deficient rotator cuffs. The system utilizes a glenoid baseplate fixed cementlessly with screws, and humeral stems that can be cemented or cementless. The update to the surgical technique does not alter the device design, materials, or principle of operation; it provides surgeons with an additional method for glenoid preparation. The device benefits patients by providing a stable, semi-constrained joint replacement for complex shoulder pathologies.

Clinical Evidence

No clinical data. Substantial equivalence is supported by design control, verification, and validation activities.

Technological Characteristics

Semi-constrained metal/polymer shoulder prosthesis. Glenoid baseplate designed for cementless fixation with screws. Humeral stems compatible with cemented or cementless application. No changes to materials or design from predicate.

Indications for Use

Indicated for patients with functional deltoid and grossly deficient rotator cuff experiencing pain/dysfunction due to severe arthropathy, failed prior joint replacement, proximal humerus fractures (trauma/pathologic), bone defects, non-inflammatory degenerative disease (osteoarthritis/avascular necrosis), inflammatory arthritis (rheumatoid), or functional deformity.

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 Reverse® Glenoid (K233481)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 5, 2025

Encore Medical L.P.
Patricia Kontoudis
Regulatory Program Manager, Surgical
9800 Metric Boulevard
Austin, Texas 78758

Re: K252141
Trade/Device Name: AltiVate Reverse® Glenoid
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: PHX
Dated: July 8, 2025
Received: July 8, 2025

Dear Patricia Kontoudis:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252141 - Patricia Kontoudis
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252141 - Patricia Kontoudis
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assistance/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,

Farzana Sharmin -S
Digitally signed by Farzana Sharmin -S
Date: 2025.08.05 18:13:28
-04'00'

Farzana Sharmin, PhD
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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AltiVate Reverse® Glenoid
Page 7 of 24

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K252141 | ? |
| Please provide the device trade name(s). | | ? |
| AltiVate Reverse® Glenoid | | |
| Please provide your Indications for Use below. | | ? |
| The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with
a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due
to: | | |
| Severe arthropathy with a grossly deficient rotator cuff; | | |
| Previously failed joint replacement with a grossly deficient rotator cuff; | | |
| Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head
fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; | | |
| Bone defect in proximal humerus; | | |
| Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural
humeral head and/or glenoid; | | |
| Inflammatory arthritis including rheumatoid arthritis; | | |
| Correction of functional deformity. | | |
| The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device
may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi
procedures. | | |
| All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use. | | |
| Please select the types of uses (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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enovis™
K252141
Page 1 of 2

# 510(k) Summary

Manufacturer: Encore Medical, L.P.
9800 Metric Boulevard
Austin, TX 78758

Contact: Ms. Patricia Kontoudis
Regulatory Program Manager, Surgical
Encore Medical, L.P.
9800 Metric Boulevard
Austin, TX 78758
Phone: [phone]
[e-mail]

Date Prepared: August 5, 2025

Device Trade Name: AltiVate Reverse® Glenoid

Classification: 21 CFR §888.3660
Class II

Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis

Common Name: Reverse Shoulder Prosthesis

Product Code: PHX

Predicate: AltiVate Reverse® Glenoid (K233481)

Indications for Use: The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- Severe arthropathy with a grossly deficient rotator cuff;
- Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head

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enovis™
K252141
Page 2 of 2

fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- Bone defect in proximal humerus;
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

## Device Description:

This 510(k) submission proposes updated Surgical Technique within labeling, to reflect alternative reaming method to prepare the glenoid surface for the AltiVate Reverse Glenoid wedge baseplate. The alternative technique does not replace the original technique; it adds a secondary method for the user. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced.

## Performance Testing:

Design Control and Verification and Validation Activities performed, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness.

## Substantial Equivalence:

There is no difference in intended use, design, material, manufacturing process, sterilization, packaging and principle of operation of the devices, or the instruments required to implant the devices.

## Conclusion:

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