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 Description

This Line Extension portfolio includes:

Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions.
Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization.
Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." It is a premarket notification to the FDA for a new component (25mm diameter reverse glenoid baseplates, glenospheres, and a humeral reverse tray) to an existing shoulder replacement system.

Based on the information provided in the document, here's a breakdown of the requested points:

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

The document does not present quantitative acceptance criteria or specific numerical performance results in a table format for this specific device modification. The performance testing section states:

Acceptance Criteria	Reported Device Performance
Suitable for intended purpose and Substantially Equivalent to predicate or reference devices with respect to non-clinical performance and design.	"The results of non-clinical performance testing and evaluations demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate or reference devices."

The tests performed were:

Range of Motion analysis (ASTM F1378)
Bone screw testing
Wear testing rationale for no new worst case
Glenoid fretting fatigue rationale for no new worst case
Humeral fatigue test rationale for no new worst case
Micromotion test (ASTM F2028)
Biocompatibility Evaluation

It's important to note that this 510(k) is for an addition/modification to an already cleared device, and the evaluation relies heavily on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing and rationales, rather than establishing entirely new performance benchmarks.

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

The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." Therefore, there was no clinical "test set" in the sense of human patient data. The "test set" consisted of components tested in laboratory/benchtop settings. The document does not specify the sample sizes (e.g., number of screws tested, number of components for micromotion) for each of the non-clinical tests.

Data Provenance: The testing was non-clinical (laboratory/benchtop). The manufacturer, Waldemar Link GmbH & Co. KG, is based in Germany.

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

Not applicable. Since no clinical testing was performed, there was no human "ground truth" to establish for a clinical test set. The "truth" for the non-clinical tests is derived from engineering and materials science principles, and standards (e.g., ASTM).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring expert adjudication was used.

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

Not applicable. This is a physical implantable medical device (shoulder replacement components), not an AI/software device that assists human readers.

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

Not applicable. This is a physical implantable medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" is based on:

Engineering design specifications
Performance requirements outlined in relevant ASTM standards (e.g., ASTM F1378 for Range of Motion, ASTM F2028 for Micromotion)
Material properties and biocompatibility standards.
Comparisons to the performance characteristics of predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. As above, this device does not utilize a training set or machine learning.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration: 3003386935
Contact Person:	Stefanie Fuchs (Regulatory Affairs)Waldemar Link GmbH & Co. KGOststraße 4-10Norderstedt, GERMANY 22844Phone: +49-40 53575-530Fax: +49-40 53575-174E-Mail: st.fuchs@link-ortho.com
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 prosthesisPHX: Shoulder Prosthesis, Reverse ConfigurationPAO: 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 K120121 K172502
	Arthrex Univers Reverse Shoulder Prosthesis System	K130129 K142863
Reason forSubmission:	Adds components to the predicate Embrace Total Shoulder System -Reverse Configuration: 25 mm diameter reverse glenoid baseplates (RGBs)in neutral, wedged, and lateralized designs with associated peripheral bonescrews, a +5mm concentric reverse tray, and lateralized glenospheres.
DeviceDescription:	This Line Extension portfolio includes:- Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutraldesigns and in wedged (10°, 15° and 20°) and lateralized variants(+3mm and +6mm). The new 25mm Ø RGB components includenew peripheral 4.5mm Ø cortical screws in lengths of 20-60mm witha reduced head diameter as compared with the predicate 4.5mm Øcortical screws cleared in K200368. The screws are available instandard and angle-stable/locking versions.- Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mmand +6mm lateralization.- Humeral Reverse Tray in a neutral (concentric) version withextended +5mm height.
Intended Use:	General indications:The LINK Embrace Shoulder System - Reverse Configuration is intendedfor reverse total shoulder arthroplasty.Indications:Primary, fracture, or revision total shoulder arthroplasty in a grossly rotatorcuff deficient joint with severe arthropathy. A functional deltoid muscle isnecessary, and the patient's joint must be anatomically and structurallysuited to receive the implants.The Reverse Glenoid Baseplate component is intended for cementlessfixation with the addition of bone screws.The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) areintended for cementless fixation.The Humeral Stems Standard without CaP (HX) are intended for cementedor cementless fixation.The Humeral Fracture Stems and Proximal Bodies are intended for cementedor cementless fixation.The Modular Stems 75mm are intended for cemented or cementless fixation.The Modular Stems, fully corundum blasted, are intended for cementlessfixation.The Modular Stems, fully polished, are intended for cemented fixation.
Comparison toPredicateDevice:	The subject Reverse Glenoid Baseplates differ from the primary predicateRGBs in that they are a smaller diameter (25 mm) and feature neutralbaseplate designs with flat or convex backsides, as well as wedged andlateralized designs. These design features are similar to the secondarypredicates.The associated peripheral bone screws differ from their primary predicateswith regard to the smaller screw head shape and anodization.
	The Glenospheres differ from their primary predicates in that they offeroptions for lateralization. Lateralized glenospheres are also found in asecondary predicate system.
	Except for the new design variations described above, which are similar tofeatures in the secondary predicates, the subject line extension componentsare the same as their corresponding components of the previously clearedEmbrace Total Shoulder System with regard to intended use, materials,manufacturing methods, packaging, and sterilization.
PerformanceTesting:	Non-clinical performance testing and analysis were provided, including:- Range of Motion analysis (ASTM F1378)- Bone screw testing- Wear testing rationale for no new worst case- Glenoid fretting fatigue rationale for no new worst case- Humeral fatigue test rationale for no new worst case- Micromotion test (ASTM F2028)- Biocompatibility Evaluation.The results of non-clinical performance testing and evaluations demonstratethat the device is suitable for its intended purpose and SubstantiallyEquivalent to the predicate or reference devices.
ClinicalTesting:	Clinical performance testing was not required to demonstrate the substantialequivalence of this device.
Conclusion:	The subject LINK Embrace Shoulder System – Reverse Configuration issubstantially equivalent to the predicate devices identified in this premarketnotification.

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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.”