· Avascular necrosis of the humeral head
· Deformity and/or limited motion
· Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
· Revision of a failed primary component
· Ununited humeral head fractures
· Cuff tear arthropathy (CTA Heads only)

The All Poly Glenoid Components are intended for cemented use.

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 cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

Device Description

The LINK Embrace Shoulder System offers diverse fixation options suitable for the majority of patient populations and indications. A wide range of stems in different configurations allows for cemented and cementless fixation.

Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368].

Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters.

CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems.

The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur).

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

Important Note: The provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (LINK Embrace Shoulder System - Anatomical Configuration). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance metrics, ground truth, experts, and reader studies are not applicable to this document, as it describes a physical shoulder implant, not an AI-powered diagnostic or therapeutic tool.

The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests and analyses to demonstrate the device's safety and effectiveness compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Range of Motion analysis (ASTM F1378)	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Glenoid loosening (ASTM F2028)	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Fatigue testing with Fretting/Corrosion assessment	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Static and post-fatigue evaluation of component Locking Mechanisms (ASTM F2009)	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Wear Rationale	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Characterization of UHMWPE sterilized EO (reference K200368)	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Biocompatibility evaluation	Not explicitly detailed, but implied to be acceptable based on the "suitable for its intended purpose and Substantially Equivalent to the predicates" conclusion.
Overall Substantial Equivalence	The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicates.

Regarding the other questions related to AI/Software Performance:

Since this document describes a physical medical implant (shoulder prosthesis) and not an AI/software device, the following questions are not applicable (N/A). The concept of "test set," "training set," "ground truth experts," and "reader studies for AI" do not apply in this context.

Sample size used for the test set and the data provenance: N/A (Not an AI/software device)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/software device)
Adjudication method for the test set: N/A (Not an AI/software device)
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: N/A (Not an AI/software device)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
The type of ground truth used: N/A (Not an AI/software device)
The sample size for the training set: N/A (Not an AI/software device)
How the ground truth for the training set was established: N/A (Not an AI/software device)

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.

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

Re: K210899

Trade/Device Name: LINK Embrace Shoulder System- Anatomical Configuration Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, KWS, PAO, HSD Dated: March 26, 2021 Received: March 29, 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

June 21, 2021

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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 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,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210899

Device Name

LINK Embrace Shoulder System - Anatomical Configuration

Indications for Use (Describe)

General indications:

The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.

Indications:

• A severely painful and/or disabled shoulder joint resulting from osteoarthritis or theumatoid arthritis

· Avascular necrosis of the humeral head
· Deformity and/or limited motion

· Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

· Revision of a failed primary component

· Ununited humeral head fractures
· Cuff tear arthropathy (CTA Heads only)

The All Poly Glenoid Components are intended for cemented use.

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 cementless fixation.

The Humeral Fracture Stems are intended for cementless 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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) Number:	K210899
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 4-10Norderstedt, GERMANY 22844Phone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: st.fuchs@linkhh.de
Date Prepared:	May 26, 2021
Trade Name:	LINK Embrace Shoulder System – Anatomical Configuration
Common Name:	Artificial Shoulder Joint Replacement
Classification Name:	Shoulder joint metal/polymer non-constrained cemented prosthesis; 21CFR §888.3650, product code KWT
	Shoulder joint metal/polymer semi-constrained cementedprosthesis; 21 CFR §888.3660, product code KWS, PAO
	Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis; 21 CFR §888.3690, product code HSD
Classification and Panel:	Class II, Orthopedic / 87
Predicate Devices:	Lima Corp. SMR Shoulder System:: K161476 [Primary Predicate]
	Biomet Corp. Comprehensive Shoulder System:: K060692.
	LINK GmbH & Co KG: LINK Embrace Shoulder System - ReverseConfiguration: K200368
Trade Name:	LINK Embrace Shoulder System – Anatomical Configuration
Device Description:	The LINK Embrace Shoulder System offers diverse fixation optionssuitable for the majority of patient populations and indications. A widerange of stems in different configurations allows for cemented andcementless fixation.
	Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368].
	Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters.
	CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems.
	The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur).
	The LINK Embrace Shoulder System is supported by a streamlined, lightweight and ergonomic instrument set.
Indications for Use:	General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.
	Indications:- A severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis- Avascular necrosis of the humeral head- Deformity and/or limited motion- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory- Revision of a failed primary component- Ununited humeral head fractures- Cuff tear arthropathy (CTA Heads only)The All Poly Glenoid Components are intended for cemented use.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 cemented or cementless fixation.
	Comparison to the predicate: The subject system is substantially equivalent to the predicates in that all are hemi or total shoulder systems intended for an anatomic configuration, all describe use for primary, revision (i.e., previously

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failed joint replacement), or fracture indications, and all describe use for cuff tear arthroplasty.

The subject system is manufactured from Ti6Al4V alloy with some components also having a CaP coating, 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 Humeral Heads (with corresponding Head Adapters) that articulate with Cemented All Poly Glenoids.

There are also minor differences between the subject and predicate systems. The subject and predicate Biomet systems include monolithic stems that mate with head adaptors and heads, while the predicate SMR system has modular stems that mate with humeral bodies, head adaptors and humeral heads. The subject CTA heads mate directly with the humeral stems, where the predicate LIMA CTA heads are used with an adapter. The subject All Poly Glenoids have 4 pegs and are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur), whereas the predicate LIMA All Poly Glenoids have 3 pegs (or a single peg design) and are available in conventional polyethylene. The subject system offers head adaptors in several offsets and a neutral version with or without suture holes. The head adaptors are assembled to the humeral stems with a taper connection and assembly screw. The use of a supplemental assembly screw and the option for suture holes differs from the adapters of the predicate systems. All systems offer various component sizes to accommodate differences in patient anatomies, although the specific dimensions of each system's components are unique. All systems feature mechanical taper connections for assembly of the humeral constructs, although the specific dimensions of each system's tapers differ. Engineering analyses and mechanical tests were conducted to demonstrate equivalent performance despite minor design differences.

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

Range of Motion analysis (ASTM F1378) -
-Glenoid loosening (ASTM F2028)
-Fatigue testing with Fretting/Corrosion assessment
Static and post-fatigue evaluation of component Locking -Mechanisms (ASTM F2009)
Wear Rationale -
Characterization of UHMWPE sterilized EO (reference -K200368)
Biocompatibility evaluation -

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	The results of non-clinical performance testing demonstrate that thedevice is suitable for its intended purpose and Substantially Equivalentto the predicates.
Clinical Testing:	Clinical performance Testing was not required to demonstrate thesubstantial equivalence of this device.
Conclusion:	The subject LINK Embrace Shoulder System - AnatomicalConfiguration is substantially equivalent to the predicate devicesidentified in this premarket notification.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”