LINK Embrace Shoulder System - Reverse Configuration

K231445 · Waldemar Link GmbH & Co. KG · PHX · Nov 16, 2023 · Orthopedic

Device Facts

• Record ID: K231445
• Device Name: LINK Embrace Shoulder System - Reverse Configuration
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: PHX · Orthopedic
• Decision Date: Nov 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty. Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants. The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws. The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation. The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation. The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation. The Modular Stems 75mm are intended for cemented or cementless fixation. The Modular Stems, fully corundum blasted, are intended for cementless fixation. The Modular Stems, fully polished, are intended for cemented fixation.

Device Story

The LINK Embrace Shoulder System is a reverse total shoulder arthroplasty prosthesis. This line extension adds 25mm diameter reverse glenoid baseplates (neutral, wedged, lateralized), peripheral bone screws, a +5mm concentric humeral tray, and lateralized glenospheres. The system replaces the natural shoulder joint in patients with rotator cuff deficiency. Implants are surgically placed by orthopedic surgeons in a clinical/hospital setting. The device restores joint function by reversing the ball-and-socket anatomy, allowing the deltoid muscle to compensate for the deficient rotator cuff. The system utilizes cementless or cemented fixation depending on the specific component and clinical requirements.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including range of motion analysis (ASTM F1378), bone screw testing, micromotion testing (ASTM F2028), and biocompatibility evaluations.

Technological Characteristics

Shoulder joint metal/polymer semi-constrained prosthesis. Components include 25mm diameter reverse glenoid baseplates, peripheral cortical screws, glenospheres, and humeral trays. Materials and manufacturing methods are consistent with the predicate Embrace system. Testing performed per ASTM F1378 (Range of Motion) and ASTM F2028 (Micromotion).

Indications for Use

Indicated for patients requiring primary, fracture, or revision total shoulder arthroplasty due to severe arthropathy with gross rotator cuff deficiency. Requires functional deltoid muscle and anatomically/structurally suitable joint.

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

• LINK Embrace Shoulder System - Reverse Configuration (K200368)
• Stryker (Wright/Tornier) Aequalis PerFORM, PerFORM+ (K161742)
• Zimmer Biomet Comprehensive Reverse Shoulder System (K080642, K120121, K172502)
• Arthrex Univers Reverse Shoulder Prosthesis System (K130129, K142863)

Submission Summary (Full Text)

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November 16, 2023

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

Waldemar Link GmbH & Co. KG % Mateusz Leszczak Regulatory Affairs Manager LinkBio Corp. 69 King Street Dover, New Jersey 07801

## Re: K231445

Trade/Device Name: LINK Embrace Shoulder System - Reverse Configuration Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, PAO Dated: October 13, 2023 Received: October 13, 2023

### Dear Mateusz Leszczak:

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.

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).

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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 OS 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 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-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 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.

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-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, Joseph P. Russell Digitally signed by Joseph P. Russell -S -5 Date: 2023.11.16 12:35:14 -05'00" for: 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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# Indications for Use

Submission Number (if known)

K231445

Device Name

LINK Embrace Shoulder System - Reverse Configuration

Indications for Use (Describe)

General Indications:

The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.

Indications:

· Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.

The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.

The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.

The Humeral Stems Standard without CaP (HX) are intended for cementless fixation.

The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation. The Modular Stems 75 mm are intended for cementless fixation.

The Modular Stems, fully corundum blasted, are intended for cementless fixation.

The Modular Stems, fully polished, are intended for cemented fixation.

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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# 510(k) Summary

| 510(k) Submitter: | Waldemar Link GmbH & Co. KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: [phone]<br>Facility Registration: 3003386935 | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Contact Person: | Stefanie Fuchs (Regulatory Affairs)<br>Waldemar Link GmbH & Co. KG<br>Oststraße 4-10<br>Norderstedt, GERMANY 22844<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] | |
| Date Prepared: | November 16, 2023 | |
| Trade Name: | LINK Embrace Shoulder System – Reverse Configuration | |
| Common Name: | Artificial Shoulder Joint Replacement | |
| Classification Name: | 21 CFR §888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis<br><br>PHX: Shoulder Prosthesis, Reverse Configuration<br><br>PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer – Additive, Cemented | |
| Classification and Panel: | Class II, Orthopedic / 87 | |
| Predicate Devices: | LINK Embrace Shoulder System – Reverse Configuration [Primary Predicate] | K200368 |
| | Stryker (Wright/Tornier) Aequalis PerFORM, PerFORM+ | K161742 |
| | Zimmer Biomet Comprehensive Reverse Shoulder System | K080642<br>K120121<br>K172502 |
| | Arthrex Univers Reverse Shoulder Prosthesis System | K130129<br>K142863 |
| Reason for<br>Submission: | Adds components to the predicate Embrace Total Shoulder System -<br>Reverse Configuration: 25 mm diameter reverse glenoid baseplates (RGBs)<br>in neutral, wedged, and lateralized designs with associated peripheral bone<br>screws, a +5mm concentric reverse tray, and lateralized glenospheres. | |
| Device<br>Description: | This Line Extension portfolio includes:<br>- Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral<br>designs and in wedged (10°, 15° and 20°) and lateralized variants<br>(+3mm and +6mm). The new 25mm Ø RGB components include<br>new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with<br>a reduced head diameter as compared with the predicate 4.5mm Ø<br>cortical screws cleared in K200368. The screws are available in<br>standard and angle-stable/locking versions.<br>- Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm<br>and +6mm lateralization.<br>- Humeral Reverse Tray in a neutral (concentric) version with<br>extended +5mm height. | |
| Intended Use: | General indications:<br>The LINK Embrace Shoulder System - Reverse Configuration is intended<br>for reverse total shoulder arthroplasty.<br>Indications:<br>Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator<br>cuff deficient joint with severe arthropathy. A functional deltoid muscle is<br>necessary, and the patient's joint must be anatomically and structurally<br>suited to receive the implants.<br>The Reverse Glenoid Baseplate component is intended for cementless<br>fixation with the addition of bone screws.<br>The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are<br>intended for cementless fixation.<br>The Humeral Stems Standard without CaP (HX) are intended for cemented<br>or cementless fixation.<br>The Humeral Fracture Stems and Proximal Bodies are intended for cemented<br>or cementless fixation.<br>The Modular Stems 75mm are intended for cemented or cementless fixation.<br>The Modular Stems, fully corundum blasted, are intended for cementless<br>fixation.<br>The Modular Stems, fully polished, are intended for cemented fixation. | |
| Comparison to<br>Predicate<br>Device: | The subject Reverse Glenoid Baseplates differ from the primary predicate<br>RGBs in that they are a smaller diameter (25 mm) and feature neutral<br>baseplate designs with flat or convex backsides, as well as wedged and<br>lateralized designs. These design features are similar to the secondary<br>predicates.<br>The associated peripheral bone screws differ from their primary predicates<br>with regard to the smaller screw head shape and anodization. | |
| | The Glenospheres differ from their primary predicates in that they offer<br>options for lateralization. Lateralized glenospheres are also found in a<br>secondary predicate system. | |
| | Except for the new design variations described above, which are similar to<br>features in the secondary predicates, the subject line extension components<br>are the same as their corresponding components of the previously cleared<br>Embrace Total Shoulder System with regard to intended use, materials,<br>manufacturing methods, packaging, and sterilization. | |
| <b>Performance<br/>Testing:</b> | Non-clinical performance testing and analysis were provided, including:<br>- Range of Motion analysis (ASTM F1378)<br>- Bone screw testing<br>- Wear testing rationale for no new worst case<br>- Glenoid fretting fatigue rationale for no new worst case<br>- Humeral fatigue test rationale for no new worst case<br>- Micromotion test (ASTM F2028)<br>- Biocompatibility Evaluation.<br><br>The results of non-clinical performance testing and evaluations demonstrate<br>that the device is suitable for its intended purpose and Substantially<br>Equivalent to the predicate or reference devices. | |
| <b>Clinical<br/>Testing:</b> | Clinical performance testing was not required to demonstrate the substantial<br>equivalence of this device. | |
| <b>Conclusion:</b> | The subject LINK Embrace Shoulder System – Reverse Configuration is<br>substantially equivalent to the predicate devices identified in this premarket<br>notification. | |

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