(272 days)
Not Found
No
The summary describes a computer-assisted surgical instrument that tracks instrument position relative to a virtual model. It does not mention any AI or ML techniques for image analysis, planning, or decision support. The system relies on tracking and visualization, not learning or pattern recognition.
No
The device is a surgical instrument intended to assist a surgeon in placing a K-wire for glenoid preparation and positioning during shoulder arthroplasty, rather than directly treating a disease or condition.
No
This device is a surgical instrument with computer-assisted tracking capabilities, intended to assist surgeons with K-wire placement and glenoid component positioning during shoulder arthroplasty. It is a tool for surgical guidance and execution, not for diagnosing a condition or disease.
No
The device description explicitly lists hardware components such as a handheld surgical instrument (COREmote with Power and Sensor Units), a Workstation (tablet, AC adapter, stand), and reusable stainless-steel probes. It also includes performance studies related to hardware aspects like battery life, sensor unit lifecycle, electrical safety, and sterilization validation.
Based on the provided text, the CORE Shoulder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CORE Shoulder System Function: The CORE Shoulder System is a surgical instrument used during surgery to assist the surgeon with placing a guide pin and positioning a glenoid component. It uses computer-assisted tracking relative to a virtual model and CT data, but it does not analyze biological specimens from the patient.
The device's function is entirely focused on surgical guidance and instrument placement within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
The CORE Shoulder System is designed for use with the following LINK Implant systems:
- LINK Embrace Shoulder System Reverse Configuration (K200368, K212992, K231445)
- LINK Embrace Shoulder System Anatomic Configuration (K210899)
Product codes (comma separated list FDA assigned to the subject device)
OHE, KWS, PHX
Device Description
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. CORE Shoulder assists the surgeon in placing the K-wire according to the preoperatively planned location. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data
Anatomical Site
glenoid, shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, Prescription Use
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:
- Battery Life
- Sensor Unit Lifecycle
- Patient Motion Risk Assessment
- Comparative testing of K-wire placement versus pre-op plan in analogue glenoid models
- Cadaver testing comparing both K-wire placement and implant position versus pre-op plan
- Accuracy testing for K-wire Placement Check feature
- Usability evaluation
- Biocompatibility Evaluation per ISO 10993-1
- Electrical safety testing per IEC 60601-1
- EMC testing
- Cybersecurity Evaluation
- Software validation testing
- Sterilization validation testing
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.
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.
Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), by Cleveland Clinic, K123122, Virtual Implant Positioning (VIP) System, by Arthrex, K222007
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 20, 2025
LinkBio Corp. Deniz Kortan Sr. Quality Manager - Digital Surgery 69 King Street Dover, New Jersey 07801
Re: K241470
Trade/Device Name: CORE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OHE, KWS, PHX Dated: January 21, 2025 Received: January 21, 2025
Dear Deniz Kortan:
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 (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.
1
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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is by Farzana Sharmin -S. The date of the signature is 2025.02.20, and the time is 14:03:17 -05'00'.
Farzana Sharmin, Ph.D. 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) K241470
Device Name CORE Shoulder System
Indications for Use (Describe)
The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
The CORE Shoulder System is designed for use with the following LINK Implant systems:
- · LINK Embrace Shoulder System Reverse Configuration (K200368, K212992, K231445)
- · LINK Embrace Shoulder System Anatomic Configuration (K210899)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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: | LinkBio Corp.
69 King Street
Dover, NJ 07801, USA
Registration Number: 3006721341 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Deniz Kortan
LinkBio Corp.
69 King Street
Dover, NJ 07801, USA
Phone: 1-800-932-0616
Email: d.kortan@linkbio.com |
| Date Prepared: | February 20, 2025 |
| Trade Name: | CORE Shoulder System |
| Common
Name: | Shoulder Arthroplasty Implantation System |
| Classification
Name: | 21 CFR §888.3660: Shoulder joint metal/polymer semi-constrained
cemented prosthesis |
| | QHE (Shoulder Arthroplasty Implantation System) |
| | KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer
Cemented) |
| | PHX (Shoulder Prosthesis, Reverse Configuration) |
| Classification
and Panel: | Class II, Orthopedic |
| Predicate
Device: | Glenoid Intelligent Reusable Instrument System (Glenoid IRIS), by
Cleveland Clinic, K123122 (Primary Predicate), and Virtual Implant
Positioning (VIP) System, by Arthrex, K222007 (Additional Predicate). |
| Reason for
Submission | New device |
| Device
Description: | The CORE Shoulder System is a handheld surgical instrument with
computer-assisted instrument tracking and is intended to assist the
surgeon with placement of the K-wire (central guide pin) used in the
preparation of the glenoid and the positioning of the glenoid component
during primary Anatomic or Reverse total shoulder arthroplasty.
CORE Shoulder assists the surgeon in placing the K-wire according to the
preoperatively planned location. The CORE Shoulder System tracks the live |
5
position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
It allows the surgeon to visually compare the planned and placed position/trajectory of the guide pin (K-wire) by referencing a virtual 3D model of the pre-operative plan and the measured location of the K-wire. The system components include the Workstation (tablet, AC adapter, stand), the handheld COREmote (single-use Power Unit and reusable Sensor Unit), and reusable stainless-steel probes of different sizes.
-
Indications for The CORE Shoulder System is a handheld surgical instrument with computer-assisted instrument tracking and is intended to assist the Use: surgeon with placement of the K-wire (central guide pin) used in the preparation of the glenoid and the positioning of the glenoid component during primary Anatomic or Reverse total shoulder arthroplasty. The CORE Shoulder System tracks the live position of the instruments relative to an untracked virtual anatomical model. It does not track the patient anatomy.
The CORE Shoulder System is designed for use with the following LINK Implant systems: -
LINK Embrace Shoulder System - Reverse Configuration (K200368, K212992, K231445)
-
LINK Embrace Shoulder System – Anatomic Configuration (K210899)
Comparison to The predicate device for the subject CORE Shoulder System is the Glenoid Predicate IRIS system.
Device:
Both the subject and predicate systems are intended to aid the surgeon in setting K-wire position (entry point and orientation) according to a patientspecific pre-operative plan for the intended glenoid implant position.
Both the predicate and subject devices rely on pre-operative planning software that uses CT data to create a virtual model of the patient's scapula and determine the K-wire position associated with the desired implant position. The predicate Glenoid IRIS uses its own proprietary software for pre-operative planning, while the CORE Shoulder uses a commercially available software legally marketed for this purpose (K170702).
Both systems assist the surgeon in visually comparing the planned and placed K-wire position by referencing a 3D model of the pre-operative plan. In the case of the predicate device, the 3D model is a physical model, and in the case of the subject CORE Shoulder device, the 3D model is a virtual model. The CORE Shoulder also provides computer-assisted instrument tracking to help target the K-wire by tracking the position of the instrument relative to an untracked virtual model. The CORE Shoulder device interacts wirelessly with the computer tablet running the CORE software to display this information. This is a technological difference from the predicate Glenoid IRIS which does not provide computer-assisted instrument tracking.
6
| | The subject and predicate devices both feature reusable Stainless Steel
components for contact with the glenoid which include a guide for drilling
the K-wires. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Both the subject and predicate devices have the same intended purpose.
There are some differences in technological characteristics, but both
systems provide a method for comparing the planned and placed K-wire
position compared to the pre-operative plan, and scientific methods exist
for evaluating the effect of the different technological characteristics on
safety and effectiveness. The performance testing provided supports the
Substantial Equivalence of the subject device for its intended purpose. |
| Performance
Testing: | Non-clinical performance testing and analysis were provided, including:
- Battery Life
- Sensor Unit Lifecycle
- Patient Motion Risk Assessment
- Comparative testing of K-wire placement versus pre-op plan in
analogue glenoid models - Cadaver testing comparing both K-wire placement and implant
position versus pre-op plan - Accuracy testing for K-wire Placement Check feature
- Usability evaluation
- Biocompatibility Evaluation per ISO 10993-1
- Electrical safety testing per IEC 60601-1
- EMC testing
- Cybersecurity Evaluation
- Software validation testing
- Sterilization validation testing
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. |
| Clinical Testing: | Clinical performance testing was not required to demonstrate the
substantial equivalence of this device. |
| Conclusion: | The subject device is substantially equivalent to the predicate device
identified in this premarket notification. |