(133 days)
No
The document describes a physical implantable medical device (shoulder prosthesis) and its components. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies listed are non-clinical tests related to the physical properties and biocompatibility of the implant.
Yes
The device is a prosthesis intended for the treatment of humeral fractures and total shoulder replacement, which are medical conditions, and aims to restore function to the shoulder joint.
No
This device is described as a "Reverse Shoulder Prosthesis" and a "Glenoid Reconstruction System (GRS) Full Wedge baseplate," which are implantable devices used for surgical replacement of parts of the shoulder joint. These are therapeutic devices, not diagnostic ones.
No
The device description clearly states it is a sterile implantable device made of Ti6Al7Nb and double coated, indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for replacing a joint in the shoulder. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of specific materials, designed for surgical implantation. This aligns with a medical device, not an IVD.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies listed are related to the mechanical and biological properties of the implant (fatigue testing, micromotion, biocompatibility, etc.), which are typical for medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX
Device Description
Glenoid Reconstruction System (GRS) Full Wedge baseplate is a Medacta Shoulder System line extension to provide a larger product offering.
It includes GRS Full Wedge baseplate and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.
The GRS Full Wedge baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability.
The GRS Full Wedge baseplate is designed to provide an interface for glenosphere coupling.
The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 4 full wedge options (10°, 15°, and 20°).
It is made of Ti6Al7Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenoid side of the gleno-humeral joint in a shoulder
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 Studies:
- DESIGN VALIDATION
- Glenoid Reconstruction System Full Wedge Baseplate Design Validation
- PERFORMANCE TESTING
- Fatigue testing on glenoid reconstruction system
- Micromotion assessment on Glenoid reconstruction system Full Wedge Baseplate according to ASTM F2028-17
- Range of Motion Assessment
- Characterization Report "Y367" Titanium + "Osprovit" Hydroxyapatite double coating on GRS Glenoid baseplate component
- Scanning electron microscopy pictures of the "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate
- Cross sectioned area of "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS Glenoid baseplate
- Rationale comparison between features of the Hydroxyapatite Osprovit coating deposited on the Medacta GRS Glenoid baseplate and on planar samples made of Ti6A17Nb, based on XRD analyses
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Key results: The information provided above supports that the Glenoid Reconstruction Systems Full Wedge baseplate implants are substantially equivalent to the primary predicate 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.
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.
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 9, 2023
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 & 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.
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp St Memphis, Tennessee 38118
Re: K231911
Trade/Device Name: Glenoid Reconstruction System - Full Wedge Baseplate Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: October 12, 2023 Received: October 16, 2023
Dear Chris Lussier:
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).
1
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 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,
Farzana
Sharmin -S
Digitally signed by Farzana Sharmin -S
Date: 2023.11.09 17:53:11 -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
2
Indications for Use
510(k) Number (if known)
K231911
Device Name
Glenoid Reconstruction System - Full Wedge Baseplate
Indications for Use (Describe)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional 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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3
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 28, 2023 Date Revised: November 9, 2023
II. Device
| Device Proprietary Name: | Glenoid Reconstruction System – Full Wedge Baseplate |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis, Reverse Configuration |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis | |
| Primary Product Code | PHX |
| Regulation Number: | 21 CFR 888.3660 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device
-
The Univers Revers Augmented Modular Glenoid System, K193372, Arthrex
Additional predicate device -
Medacta Glenoid Reconstruction System, K213459, Medacta International SA
-
Aequalis Perform Reversed, K161742, Wright Medical
Reference device
-
Medacta Shoulder System, K170452, Medacta International SA
4
IV. Device Description
Glenoid Reconstruction System (GRS) Full Wedge baseplate is a Medacta Shoulder System line extension to provide a larger product offering.
It includes GRS Full Wedge baseplate and central screws, sterile implantable devices used to replace only the glenoid side of the gleno-humeral joint in a shoulder reverse configuration.
The GRS Full Wedge baseplate, intended for cementless application, is designed to be fixed into the glenoid bone by means of both a press-fit central post and Glenoid Polyaxial Screws. If desired, a GRS Central Screw can be used to provide additional stability.
The GRS Full Wedge baseplate is designed to provide an interface for glenosphere coupling.
The subject baseplate is available in two taper diameters (024.5 and 027) with two different lengths (20 and 30 mm) of the central post and 4 full wedge options (10°, 15°, and 20°).
It is made of Ti6Al7Nb according to ISO 5832-11 and double coated with Ti coating according to ASTM F1580-18 and HA coating according to ASTM F1185-03.
V. Indications for Use
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
VI. Comparison of Technological Characteristics
The subject and predicate devices (K193372, K213459, and K161742) are substantially equivalent with regards to the following characteristics:
- general design;
- angle correction (except the predicate K213459); ●
5
- fixation:
- . biocompatibility:
- device usage:
- sterility: ●
- shelf-life: and ●
- packaging. ●
The subject implants differ from the predicate devices K213459 as follows:
- angle correction; ●
Discussion
Medacta International SA has not made any change to the indications for use, general design and shape, fixation, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the Glenoid Reconstruction System implants to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, performance testing was conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- . DESIGN VALIDATION
- Glenoid Reconstruction System Full Wedge Baseplate Design Validation O
- PERFORMANCE TESTING ●
- Fatigue testing on glenoid reconstruction system O
- Micromotion assessment on Glenoid reconstruction system Full Wedge Baseplate according o to ASTM F2028-17
- Range of Motion Assessment о
- Characterization Report "Y367" Titanium + "Osprovit" Hydroxyapatite double coating on o GRS Glenoid baseplate component
- Scanning electron microscopy pictures of the "Y367" Titanium + "Osprovit" HA implant о surfaces of the GRS Glenoid baseplate
- Cross sectioned area of "Y367" Titanium + "Osprovit" HA implant surfaces of the GRS о Glenoid baseplate
- Rationale comparison between features of the Hydroxyapatite Osprovit coating deposited on о the Medacta GRS Glenoid baseplate and on planar samples made of Ti6A17Nb, based on XRD analyses
6
- PYROGENICITY .
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is o equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination o
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation .
Clinical Studies:
- . No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the Glenoid Reconstruction Systems Full Wedge baseplate implants are substantially equivalent to the primary predicate device.