LINK Embrace Shoulder System- Anatomical Configuration

{0}------------------------------------------------ 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. 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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 {2}------------------------------------------------ ## 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) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <table style="border:none"><tr><td><span style="display:inline-block; min-width:20px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </td><td><span style="display:inline-block; min-width:20px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="display:inline-block; min-width:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; min-width:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span style="display:inline-block; min-width:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; min-width:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: +49-40-539950<br>Facility Registration #:3003386935 | | Contact Person: | Waldemar Link GmbH & Co. KG<br>Stefanie Fuchs (Regulatory Affairs)<br>Oststraße 4-10<br>Norderstedt, GERMANY 22844<br>Phone: +49-40 53995-530<br>Fax: +49-40 53995-174<br>E-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; 21<br>CFR §888.3650, product code KWT | | | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis; 21 CFR §888.3660, product code KWS, PAO | | | Shoulder joint humeral (hemi-shoulder) metallic uncemented<br>prosthesis; 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 - Reverse<br>Configuration: K200368 | | Trade Name: | LINK Embrace Shoulder System – Anatomical Configuration | | Device Description: | The LINK Embrace Shoulder System offers diverse fixation options<br>suitable for the majority of patient populations and indications. A wide<br>range of stems in different configurations allows for cemented and<br>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. | | Indications for Use: | General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty. | | | Indications:<br>- A severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis<br>- Avascular necrosis of the humeral head<br>- Deformity and/or limited motion<br>- 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<br>- Revision of a failed primary component<br>- Ununited humeral head fractures<br>- Cuff tear arthropathy (CTA Heads only)<br>The All Poly Glenoid Components are intended for cemented use.<br>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.<br>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 | {4}------------------------------------------------ {5}------------------------------------------------ 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 - {6}------------------------------------------------ | | The results of non-clinical performance testing demonstrate that the<br>device is suitable for its intended purpose and Substantially Equivalent<br>to the predicates. | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical Testing: | Clinical performance Testing was not required to demonstrate the<br>substantial equivalence of this device. | | Conclusion: | The subject LINK Embrace Shoulder System - Anatomical<br>Configuration is substantially equivalent to the predicate devices<br>identified in this premarket notification. |