(357 days)
Not Found
No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a system for reverse total shoulder arthroplasty, which means it is used to surgically replace a damaged shoulder joint to restore its function and alleviate pain, thus providing a therapeutic benefit to the patient.
No
This device is an implantable shoulder arthroplasty system, not a diagnostic tool. Its purpose is to replace a damaged shoulder joint.
No
The device description clearly outlines multiple hardware components made of materials like Ti6Al4V and CoCrMo, intended for surgical implantation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "reverse total shoulder arthroplasty," which is a surgical procedure to replace the shoulder joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a system of implants (stems, baseplate, glenosphere, trays, inserts) designed to be surgically implanted into the shoulder joint.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the examination of bodily specimens.
Therefore, the LINK Embrace Shoulder System - Reverse Configuration is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, HSD, PAO
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 Phosphate 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, humerus, glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing and analysis were provided, including:
- 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)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K110598, K100858, K101263, K181611, K130390, K113069, K080642, K132239
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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:
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.
| 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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3
510(k) Summary
| 510(k)
Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration: 3003386935 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-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 and
Classification
Name: | 21 CFR §888.3660: Shoulder joint metal/polymer semi-constrained
cemented prosthesis; |
| | 21 CFR §888.3690: Shoulder joint humeral (hemi-shoulder) metallic
uncemented 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 |
| 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 |
4
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.
Intended Use: 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 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)
5
- -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.