(247 days)
No
The document describes a mechanical implant (shoulder prosthesis) and its components. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a prosthesis intended for treatment of humeral fractures and total shoulder replacement, directly treating a medical condition.
No
The device is a prosthesis intended for joint replacement, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of titanium alloy intended for surgical implantation in the shoulder joint. The performance studies also focus on mechanical testing of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of humeral fractures and total shoulder replacement in patients with specific shoulder conditions. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a physical implant (a threaded glenoid baseplate) made of titanium alloy, designed to replace part of the shoulder joint. This is a medical device intended for implantation, not for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing diagnostic information based on laboratory tests
- Mentioning any form of in vitro analysis
The device described is a surgical implant used in a surgical procedure to treat a musculoskeletal condition.
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 failed joint replacement and a grossly rotator cuff deficient shoulder joint.
The patient’s joint must be anatomically 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX
Device Description
The purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.
The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).
The Medacta Shoulder System is similar to predicate devices Tornier’s Aequalis Reversed Shoulder Prosthesis (K132285), Encore’s Reverse Shoulder (K041066) and reference device Medacta’s Shoulder System (K170452).
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 Studies
- Performance Tests
- Fatigue Testing: ASTM F1378-12: Standard Specification For Shoulder O Prostheses
- Micromotions Assessment In Reverse Configuration: ASTM F2028-14: Standards o Test Methods For Dynamic Evaluation of Glenoid Loosening Or Disassociation Prostheses
- Coating Tests
- o Glenoid Baseplate: Characterization Report Titanium Y367 Coating on Threaded Glenoid Baseplate Medacta
- Pyrogenicity
- o Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination; and
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or o pyrogen free.
Clinical Studies
- No clinical studies were conducted.
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
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December 13, 2017
Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K171058
Trade/Device Name: Medacta Shoulder System: Threaded Glenoid 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: November 10, 2017 Received: November 13, 2017
Dear Ms. Rose:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171058
Device Name
Medacta Shoulder System: Threaded Glenoid 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 failed joint replacement and a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Medacta Shoulder System: Threaded Glenoid Baseplate Traditional 510(k)
3.0 510(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 Affairs Manager Date Prepared: April 07, 2017 Date Revised: December 11, 2017
II. Device
| Device Proprietary Name: | Medacta Shoulder System: Threaded Glenoid 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 | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary Predicate:
- Aequalis Reversed Shoulder Prosthesis, K132285, Tornier, SAS ●
- Encore Reverse Shoulder, K041066, Encore Medical, L.P. ●
Reference Devices
- Evolis Total Knee System, K081023, Medacta International, SA ●
- Medacta Shoulder System, K170452, Medacta International, SA
IV. Device Description
The purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is
4
an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.
The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).
The Medacta Shoulder System is similar to predicate devices Tornier's Aequalis Reversed Shoulder Prosthesis (K132285), Encore's Reverse Shoulder (K041066) and reference device Medacta's Shoulder System (K170452).
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 and a grossly rotator cuff deficient 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.
VI. Comparison of Technological Characteristics
The Medacta Shoulder System: Threaded Glenoid Baseplate and the predicate devices share the following characteristics:
- Indications for Use
- Materials ●
- Design ●
- Sterile ●
- Coating ●
- Threaded ●
- Method of Fixation
- Lengths
The Medacta Shoulder System: Threaded Glenoid Baseplate is technologically different from the predicate devices as follows:
5
Diameters .
The Medacta Shoulder System: Threaded Glenoid Baseplate is manufactured from Titanium Alloy (Ti6-Al 4-V) according to ISO 5832-3:1996 Implants For Surgery - Metallic Materials -Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy with a Titanium Y367 coating.
These materials have an extensive amount of biocompatibility history that has been provided in the listed predicate devices' 510(k) submissions; Tornier's Aequalis Reversed Shoulder Prosthesis (K132285). Encore's Reverse Shoulder (K041066) and reference device Medacta's Shoulder System (K170452). The Titanium Y367 coating used on the Medacta Shoulder System: Threaded Glenoid Baseplate is provided by Eurocoating S.p.A. The Titanium Y367 coating was previously reviewed in reference device Medacta's Evolis Total Knee System (K081023).
Additional biocompatibility testing was deemed unnecessary because the materials are the same or similar to the predicate devices and follow standards for manufacturing.
A comparison of the subject and predicate devices are provided in the table below.
| Parameters | Medacta Shoulder
System
(Subject Device) | Tornier Aequalis
Reversed Shoulder
Prosthesis
K132285
(Predicate Device) | Encore Reverse
Shoulder
K041066
(Predicate Device) |
|-----------------------|------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Coating | Titanium
(ASTM F1580) | Titanium
(ASTM F1580) | Hydroxyapatite
(ASTM F1185)
3DMatrix Coating |
| Diameter | Ø24.5 mm and Ø27 mm | Ø25 mm and Ø29 mm | Ø26 mm |
| Post Length | 25 mm, 30 mm and 35 mm | 20 mm, 25 mm, 30 mm, 35 mm, 40 mm,
45 mm and 50 mm | 30 mm |
| Method of
Fixation | Uncemented | Uncemented | Uncemented |
| Post Design | Threaded | Threaded | Threaded |
| Device usage | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with
permanent >30 day | Implant with
permanent >30 day | Implant with
permanent >30 day |
| Sterilization | Gamma | Gamma | Gamma |
Technological comparison
6
Discussion
As seen above, the technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The Medacta Shoulder System: Threaded Glenoid Baseplate is the same or similar to the predicate devices in terms of intended use, materials of construction, design, coating, threaded, method of fixation, lengths and sterility. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the Medacta Shoulder System: Threaded Glenoid Baseplate to the identified predicate devices.
Performance Data VII.
The following mechanical tests are being provided in support of a substantial equivalence determination. Based on the risk analysis, testing was conducted to written protocols with acceptance criteria that were based on standards.
Non-Clinical Studies
- Performance Tests ●
- Fatigue Testing: ASTM F1378-12: Standard Specification For Shoulder O Prostheses
- Micromotions Assessment In Reverse Configuration: ASTM F2028-14: Standards o Test Methods For Dynamic Evaluation of Glenoid Loosening Or Disassociation Prostheses
- Coating Tests ●
- o Glenoid Baseplate: Characterization Report Titanium Y367 Coating on Threaded Glenoid Baseplate Medacta
- Pyrogenicity
- o Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination; and
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or o pyrogen free.
Clinical Studies
- No clinical studies were conducted. ●
Conclusion VIII.
The information provided above supports that the Medacta Shoulder System: Threaded Glenoid Baseplate is as safe and effective as the predicate devices. Therefore, it is concluded that the Medacta Shoulder System: Threaded Glenoid Baseplate is substantially equivalent to the predicate devices.