(182 days)
Not Found
No
The 510(k) summary describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, image processing, AI, or ML in the intended use, device description, or performance studies. The performance studies focus on mechanical properties and biocompatibility.
Yes
The device is an implant for total shoulder arthroplasty, which is a medical procedure performed to treat a condition or disease (severe arthropathy and rotator cuff deficiency), thereby acting as a therapeutic device.
No
Explanation: The device is an implant for total shoulder arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines physical components (baseplates, screws, glenospheres, humeral trays, stems) which are hardware implants for shoulder arthroplasty. There is no mention of software as the primary or sole component.
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 involving the implantation of a medical device into the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The device is described as a system of implants (baseplates, glenospheres, humeral stems) designed to be surgically implanted in the shoulder joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on in vitro testing.
This device is clearly a surgically implanted medical device, not an in vitro diagnostic product.
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 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) are intended for cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation. The Modular Stems 75 mm are intended for cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX, PAO
Device Description
This Line Extension portfolio includes:
- Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions.
- Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization.
- Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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)
- Bone screw testing
- Wear testing rationale for no new worst case
- Glenoid fretting fatigue rationale for no new worst case
- Humeral fatigue test rationale for no new worst case
- Micromotion test (ASTM F2028)
- Biocompatibility Evaluation.
The results of non-clinical performance testing and evaluations demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate or reference devices.
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.
K200368, K161742, K080642, K120121, K172502, K130129, K142863
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
November 16, 2023
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side.
Waldemar Link GmbH & Co. KG % Mateusz Leszczak Regulatory Affairs Manager LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K231445
Trade/Device Name: LINK Embrace 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, PAO Dated: October 13, 2023 Received: October 13, 2023
Dear Mateusz Leszczak:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Joseph P. Russell Digitally signed by Joseph P. Russell -S -5 Date: 2023.11.16 12:35:14 -05'00" for: Farzana Sharmin, PhD 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
Submission Number (if known)
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 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) are intended for cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation. The Modular Stems 75 mm are intended for 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. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration: 3003386935 | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Contact Person: | Stefanie Fuchs (Regulatory Affairs)
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53575-530
Fax: +49-40 53575-174
E-Mail: st.fuchs@link-ortho.com | |
| Date Prepared: | November 16, 2023 | |
| Trade Name: | LINK Embrace Shoulder System – Reverse Configuration | |
| Common Name: | Artificial Shoulder Joint Replacement | |
| Classification Name: | 21 CFR §888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis
PHX: Shoulder Prosthesis, Reverse Configuration
PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer – Additive, Cemented | |
| Classification and Panel: | Class II, Orthopedic / 87 | |
| Predicate Devices: | LINK Embrace Shoulder System – Reverse Configuration [Primary Predicate] | K200368 |
| | Stryker (Wright/Tornier) Aequalis PerFORM, PerFORM+ | K161742 |
| | Zimmer Biomet Comprehensive Reverse Shoulder System | K080642
K120121
K172502 |
| | Arthrex Univers Reverse Shoulder Prosthesis System | K130129
K142863 |
| Reason for
Submission: | Adds components to the predicate Embrace Total Shoulder System -
Reverse Configuration: 25 mm diameter reverse glenoid baseplates (RGBs)
in neutral, wedged, and lateralized designs with associated peripheral bone
screws, a +5mm concentric reverse tray, and lateralized glenospheres. | |
| Device
Description: | This Line Extension portfolio includes:
- Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral
designs and in wedged (10°, 15° and 20°) and lateralized variants
(+3mm and +6mm). The new 25mm Ø RGB components include
new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with
a reduced head diameter as compared with the predicate 4.5mm Ø
cortical screws cleared in K200368. The screws are available in
standard and angle-stable/locking versions. - Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm
and +6mm lateralization. - Humeral Reverse Tray in a neutral (concentric) version with
extended +5mm height. | |
| Intended Use: | 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 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) 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. | |
| Comparison to
Predicate
Device: | The subject Reverse Glenoid Baseplates differ from the primary predicate
RGBs in that they are a smaller diameter (25 mm) and feature neutral
baseplate designs with flat or convex backsides, as well as wedged and
lateralized designs. These design features are similar to the secondary
predicates.
The associated peripheral bone screws differ from their primary predicates
with regard to the smaller screw head shape and anodization. | |
| | The Glenospheres differ from their primary predicates in that they offer
options for lateralization. Lateralized glenospheres are also found in a
secondary predicate system. | |
| | Except for the new design variations described above, which are similar to
features in the secondary predicates, the subject line extension components
are the same as their corresponding components of the previously cleared
Embrace Total Shoulder System with regard to intended use, materials,
manufacturing methods, packaging, and sterilization. | |
| Performance
Testing: | Non-clinical performance testing and analysis were provided, including: - Range of Motion analysis (ASTM F1378)
- Bone screw testing
- Wear testing rationale for no new worst case
- Glenoid fretting fatigue rationale for no new worst case
- Humeral fatigue test rationale for no new worst case
- Micromotion test (ASTM F2028)
- Biocompatibility Evaluation.
The results of non-clinical performance testing and evaluations demonstrate
that the device is suitable for its intended purpose and Substantially
Equivalent to the predicate or reference devices. | |
| 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. | |
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