(59 days)
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 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) and Short without CaP (HX) are intended for cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for 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.
This system adds modular humeral stem components to the LINK Embrace Shoulder System – Reverse Configuration, comprised of Proximal Bodies and Modular Stems. The modular Proximal Bodies (Ti6A4V) are available in several sizes and heights. The Proximal Bodies feature a spiked surface, and m-l and a-p holes for suture fixation. The Proximal Bodies feature a proximal modular taper connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.
The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.
The provided text is a 510(k) summary for the LINK® Embrace Shoulder System - Reverse Configuration. This document describes a medical device, specifically a shoulder prosthesis, and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or any study that proves such a device meets acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them, as this information is not present in the provided text.
The document focuses on:
- Device Description: A shoulder joint replacement system, specifically an update adding modular humeral stem components.
- Indications for Use: When and for whom the device is intended.
- Comparison to Predicate Devices: Demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices, primarily by comparing materials,
sterilization, packaging, and general design principles. - Performance Testing: Mentioning non-clinical performance tests (Range of Motion analysis, Fatigue testing with Fretting/Corrosion assessment, and post-fatigue disassembly tests)
to show mechanical safety and performance, but these are for the physical implant, not an AI component. - No Clinical Testing: Explicitly states that clinical performance testing was not required to demonstrate substantial equivalence for this device.
In summary, the provided text describes a conventional physical medical implant, not an AI/ML-driven device.
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November 18, 2021
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Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs LinkBio Corp 69 King Street Dover, New Jersey 07801
Re: K212992
Trade/Device Name: LINK® Embrace Shoulder System - Reverse Configuration Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented rosthesis Regulatory Class: Class II Product Code: PHX, HSD, PAO Dated: September 20, 2021 Received: September 20, 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
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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 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,
For Jiping Chen, Ph.D., M.P.H. Acting Division 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) K212992
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 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) and Short without CaP (HX) are intended for cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for 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.
| 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 |
|---|---|
| ContactPerson: | LinkBio Corp.Terry Sheridan Powell (Regulatory Affairs)LinkBio Corp.69 King StreetDover, NJ 07801E-Mail: t.powell@linkbio.com |
| Date Prepared: | November 17, 2021 |
| Trade Name: | LINK® Embrace Shoulder System - Reverse Configuration |
| CommonName: | Artificial Shoulder Joint Replacement |
| ClassificationName: | 21 CFR §888.3660: Shoulder joint metal/polymer semi-constrainedcemented prosthesisPHX: Shoulder Prosthesis, Reverse ConfigurationPAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer +Additive, Cemented21 CFR §888.3690: Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesisHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Classificationand Panel: | Class II, Orthopedic / 87 |
| PredicateDevices: | Waldemar Link GmbH & Co KG LINK Embrace Total Shoulder System –Reverse Configuration [K200368 – Primary Predicate]Lima Corp. SMR Reverse Shoulder System [K110598]: Additional 510ksfor the system include K100858, K101263Integra Titan Reverse Shoulder SystemK173717, K181999, K190588 |
| Reason forSubmission | Adds Modular Humeral Stem Components to the predicate Embrace TotalShoulder System |
| DeviceDescription: | This system adds modular humeral stem components to the LINK EmbraceShoulder System – Reverse Configuration, comprised of Proximal Bodiesand Modular Stems.The modular Proximal Bodies (Ti6A4V) are available in several sizes andheights. The Proximal Bodies feature a spiked surface, and m-l and a-p holesfor suture fixation. The Proximal Bodies feature a proximal modular taper |
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connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.
The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.
General indications: Intended Use: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Device:
Testing:
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) and Short 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. The subject modular humeral stem components are substantially equivalent Comparison to Predicate to the predicate monoblock humeral stem components of the Embrace System in that they are used with the same Embrace Reverse Tray, Reverse Liner, Glenosphere, and Reverse Glenoid Baseplates and Screws for reverse
total shoulder arthroplasty for the same indications. The subject modular humeral stems are manufactured from the same materials as the predicate Embrace system components, and are sterilized and packaged the same way.
The modularity of the subject humeral stem components is similar to the modularity found in the competitive predicate devices.
Performance Non-clinical performance testing and analysis were provided, including:
- Range of Motion analysis (ASTM F1378) --
- Fatigue testing with Fretting/Corrosion assessment and post-fatigue disassembly tests
The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate or reference devices.
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| Clinical | Clinical performance testing was not required to demonstrate the substantial |
|---|---|
| Testing: | equivalence of this device. |
| Conclusion: | The subject LINK Embrace Shoulder System ">– Reverse Configuration issubstantially equivalent to the predicate devices identified in this premarketnotification. |
§ 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.”