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 Baseplate 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) and Short without CaP (HX), are intended or cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

Device Description

Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to reverse tray components for rTSA configurations. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phospate coated versions. Humeral fracture stems are also available.

The Reverse Glenoid Baseplate (Ti6Al4V) hosts a central Bone Screw and up to 4 peripheral Bone Screws. The system includes anglestable (locking screws), polyaxial anglestable and standard screw fixation with cortical and cancellous thread designs. The baseplate's backside and central peg feature a porous titanium surface for biologic fixation. The Reverse Glenoid Baseplate is assembled with a CoCrMo Glenosphere for rTSA.

The LINK Embrace Shoulder System - Reverse Configuration offers Glenospheres in several diameters. And neutral and eccentric designs. The Embrace Glenospheres are connected to the Reverse Baseplate by means of a taper and locking screw.

Reverse Trays (CoCrMo) are available in neutral, inclined and offset versions, which are combined with Reverse Inserts (polyethylene) in neutral and 10° & 20° inclined versions, enabling the surgeon to adjust the mechanical parameters in different spatial planes (e.g. retroversion and inclination) independently from each other. In addition, different Insert heights are available.

The reverse inserts are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur®).

The LINK Embrace Shoulder System – Reverse Configuration is supported by a streamlined, lightweight and ergonomic instrument set.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than proving the device meets specific performance criteria through clinical studies, AI algorithm validation, or human-in-the-loop performance evaluation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer questions related to AI performance, sample sizes for test/training sets, expert consensus, or MRMC studies. The document explicitly states:

"Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate that the device is suitable for its intended purpose and substantially equivalent to predicate devices. These tests are primarily mechanical and material characterization tests, not studies assessing clinical outcomes or AI algorithm performance.

Here's what I can extract from the provided text regarding the non-clinical testing:

Summary of Non-Clinical Performance Testing (as provided in the document):

Test Type	Relevant Standard (if mentioned)	Purpose as Stated in Document
Range of Motion analysis	ASTM F1378	To assess the device's range of motion characteristics.
Fatigue testing with Fretting/Corrosion assessment	N/A	To evaluate the device's durability and resistance to wear and corrosion under cyclic loading.
Glenoid baseplate loosening	ASTM F2028	To assess the stability of the glenoid baseplate fixation.
Reverse Baseplate/Glenosphere Component Disassociation/Taper Connection Test	ASTM F2028	To ensure the robust connection and prevent disassociation of these components.
Reverse baseplate and insert disassembly (lever-out, push-out, torque-out) testing	ASTM F1820	To evaluate the mechanical integrity and resistance to disassembly of the baseplate and insert.
Bone screw testing	ASTM F543	To assess the strength and performance of the bone screws used for fixation.
Wear rationale	N/A	To analyze and justify the wear characteristics of the device materials.
Impingement Testing	ASTM F2582	To assess potential impingement phenomena within the shoulder system.
Characterization of UHMWPE sterilized by EO	N/A	To ensure the properties of the Ultra-High Molecular Weight Polyethylene are maintained after ethylene oxide sterilization.
Characterization of TrabecuLink porous surfaces	N/A	To assess the features and properties of the porous titanium surfaces for biologic fixation.

Study Details from the provided document (where applicable):

Sample sizes: Not specified for any of the non-clinical tests. These would typically be determined by the specific ASTM standards or internal validation protocols.
Data provenance: Not explicitly stated, but these are laboratory-based, non-clinical tests likely conducted by the manufacturer or a contracted testing facility.
Experts and Ground Truth: Not applicable in the context of this 510(k) summary, as it describes non-clinical mechanical testing, not clinical studies or AI algorithm validation requiring human expert consensus.
Adjudication method: Not applicable.
MRMC Comparative Effectiveness Study: Not performed (as per "Clinical performance testing was not required").
Standalone Performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
Type of Ground Truth Used: Not applicable for non-clinical, mechanical testing. The "ground truth" would be the measured physical properties and performance against specified engineering criteria.
Training Set Sample Size & Ground Truth Establishment: Not applicable, as this document does not describe the development or validation of an AI algorithm.

Conclusion stated in the document: The results of the non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate devices.

Summary

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February 5, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs Link Bio Corp. 69 King Street Dover, New Jersey 07801

Re: K200368

Trade/Device Name: LINK Embrace Total 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, HSD, PAO Dated: January 8, 2021 Received: January 8, 2021

Dear Terry Powell:

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael Owens 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

510(k) Number (if known) K200368

Device Name

LINK Embrace Shoulder System - Reverse Configuration

Indications for Use (Describe)

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

Indications:

The Reverse Baseplate 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) and Short without CaP (HX), are intended or cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

Type of Use (Select one or both, as applicable)
区 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:	Waldemar Link GmbH & Co. KGStefanie Fuchs (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyPhone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: st.fuchs@linkhh.de
Date Prepared:	February 5, 2021
Trade Name:	LINK Embrace Shoulder System - Reverse Configuration
Common Name:	Artificial Shoulder Joint Replacement
Regulation andClassificationName:	21 CFR §888.3660: Shoulder joint metal/polymer semi-constrainedcemented prosthesis;
	21 CFR §888.3690: Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis
	Product codes: PHX- Shoulder Prosthesis, Reverse Configuration;
	HSD- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented;
	PAO- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive,Cemented
Predicate	Primary Predicate:
Devices:	Lima Corp. SMR Reverse Shoulder System: K110598
	Additional Predicates:
	Lima Corp. SMR Reverse Shoulder System: K100858, K101263
	Biomet Corp. Comprehensive Reverse Shoulder System: K181611,K130390, K113069, K080642, K132239
DeviceDescription:	Humeral Stems (Ti6Al4V) are available in monoblock designs, and featurea proximal modular taper connection for assembly to reverse tray componentsfor rTSA configurations. The monoblock Humeral Stems are available inStandard Stems and Short Stems with a broad size spectrum, and in non-coatedand Calcium Phospate coated versions. Humeral fracture stems are also available.
	The Reverse Glenoid Baseplate (Ti6Al4V) hosts a central Bone Screw and up to 4peripheral Bone Screws. The system includes anglestable(locking screws), polyaxial anglestable and standard screw fixation withcortical and cancellous thread designs. The baseplate's backside andcentral peg feature a porous titanium surface for biologic fixation. TheReverse Glenoid Baseplate is assembled with a CoCrMo Glenosphere for rTSA.
	The LINK Embrace Shoulder System - Reverse Configuration offers Glenospheresin several diameters. And neutral and eccentric designs. The

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Embrace Glenospheres are connected to the Reverse Baseplate by means of a taper and locking screw.

The reverse inserts are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur®).

The LINK Embrace Shoulder System – Reverse Configuration is supported by a streamlined, lightweight and ergonomic instrument set.

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

Indications:

The Reverse Baseplate 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) and Short without CaP (HX), are intended for cemented or cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

The subject system is substantially equivalent to the predicates in that all are total Comparison to Predicate Device: shoulder systems intended for a reverse configuration, all describe use for primary, revision (i.e., previously failed joint replacement), or fracture indications, and all describe use for grossly rotator cuff deficient joints with severe arthropathy.
The predicate system is manufactured from Ti6Al4V alloy, CoCrMo alloy, and UHMWPE, like the predicates.

The subject and predicate systems include a range of humeral stems for cemented or cementless fixation within the humerus, which are assembled to trays with polyethylene liners that articulate with a metal glenosphere attached to a glenoid baseplate that is fixed to the glenoid with bone screws.

Performance Non-clinical performance testing and analysis were provided, including:

Testing:

Range of Motion analysis (ASTM F1378) -
-Fatigue testing with Fretting/Corrosion assessment
-Glenoid baseplate loosening (ASTM F2028)
-Reverse Baseplate/Glenosphere Component Disassociation/Taper Connection Test (ASTM F2028)
-Reverse baseplate and insert disassembly (lever-out, push-out, torqueout) testing (ASTM F1820)

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-Bone screw testing (ASTM F543)
-Wear rationale
Impingement Testing (ASTM F2582) -
-Characterization of UHMWPE sterilized by EO
-Characterization of TrabecuLink porous surfaces

The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicates.

Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device.
Conclusion: The subject LINK Embrace Shoulder System - Reverse Configuration is substantially equivalent to the predicate devices identified in this premarket notification.

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.”