(141 days)
No
The device description focuses on the mechanical components and materials of a shoulder prosthesis, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical mechanical and material tests.
Yes
The device is a prosthesis indicated for treating humeral fractures and for total shoulder replacement in patients with severe arthropathy or a previously failed joint replacement, which are clear therapeutic applications.
No
The device is a modular shoulder prosthesis system intended for surgical implantation to treat humeral fractures and for total shoulder replacement. It is a therapy device, not a diagnostic one.
No
The device description clearly outlines multiple physical components made of various materials (titanium alloy, CoCr, polyethylene) intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided text describes a surgical implant intended to replace a damaged shoulder joint within the human body (in vivo). It is a physical prosthesis made of various materials.
- Intended Use: The intended use is for the treatment of humeral fractures and shoulder replacement, which are surgical procedures involving the implantation of a device.
The description clearly indicates a medical device used for surgical intervention and not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
Product codes
KWS
Device Description
The Medacta Anatomic Shoulder Prosthesis is a modular system intended to be used for anatomical shoulder arthroplasty.
The Medacta Anatomic Shoulder Prosthesis is composed of the following components:
- . Standard Humeral Diaphysis - Cementless (sizes 6 to 16)
- Standard Humeral Diaphysis Cemented (sizes 6 to 16)
- Humeral Anatomical Metaphysis Cementless (128°, 135° and 142° inclinations, sizes 6 to 16)
- Humeral Anatomical Metaphysis Cemented (128°, 135° and 142° inclinations, sizes 6 to 16)
- Double Eccenter
- Cobalt-Chromium Humeral Head (10 sizes, Ø 40 mm to Ø 58 mm)
- Highcross PE Pegged Glenoid (10 sizes, Ø 40 mm to Ø 58 mm)
- Humeral Stem Screw
The Standard Humeral Diaphysis and the Humeral Anatomical Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Humeral Stem Screw. The Double Eccenter is also connected to the Humeral Anatomical Metaphysis by means of a press-fit cylinder and a securing screw. The Cobalt-Chromium Humeral Head is coupled to a Double Eccenter by means of a taper Morse connection.
The Glenoid Anatomical Implant is composed of the Highcross PE Pegged Glenoid only, which is cemented into the glenoid bone.
The Medacta Anatomic Shoulder Prosthesis components are single-use only, are provided sterile via gamma irradiation or ethylene oxide, and are packaged individually.
The standard humeral diaphysis, humeral anatomical metaphysis, double eccenter, and humeral stem screw are manufactured from titanium alloy. The humeral head is manufactured from CoCr, and the highcross glenoid is manufactured from polyethylene.
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:
- Coating characterization studies: Metallographic, SEM, and XRD analyses
- Mechanical Testing:
- Fatigue Testing in accordance with ASTM F1378-12 and ISO 7206-4 Third Edition 2010-06-15
- Wear Testing in accordance with ASTM F1378-12, ASTM F2028-14, ISO 14242-1:2002, ISO 14242-2:2000, and ISO 17853:2011
- Range of Motion Analysis
- Micromotion Assessment in accordance with ASTM F2028-14, ASTM F1839-08 (Reapproved 2012), and ASTM F1378-12
- Axial Disassembly Testing in accordance with ASTM F2009-00 (Reapproved 2011) and ASTM F1378-12
- Cadaver Testing
- Sterilization Validation in accordance with AAMI/ANSI/ISO 11137-1:2006 (R2015), AMI/ANSI/ISO 11137-2:2013, and AAMI/ANSI/ISO 11135:2014
- Ethylene Oxide Residuals in accordance with AAMI/ANSI/ISO 10993-7:2008(R)2012
- Bacterial Endotoxin Testing (LAL Method)
- Packaging validation in accordance with ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15
- Shelf-life studies in accordance with ISO 11607-1 First Edition 2006-04-15 and ASTM F1980-16
Key results: The performance data provided supports the substantial equivalence determination. Although there is a minor difference in surface treatment between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083439, K101996, K992065, K122698, K994393
Reference Device(s)
K170452, K092265, K060209, K072857
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Ms. Roshana Ahmed, M.A., RAC Associate Director, Regulatory Affairs Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
August 16, 2017
Re: K170910
Trade/Device Name: Medacta Anatomic Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS Dated: July 17, 2017 Received: July 18, 2017
Dear Ms. Ahmed:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
Indications for Use
510(k) Number (if known)
Device Name
Medacta Anatomic Shoulder Prosthesis
Indications for Use (Describe)
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
3.0 510(k) Summary
Submitter I.
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: July 17, 2017
II. Device
| Device Proprietary Name: | Medacta Anatomic Shoulder Prosthesis |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis System |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulation Number: | 21 CFR 888.3660 |
| Product Code: | KWS |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
- o Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA)
Additional Predicates:
- Depuy Global Unite Shoulder System, K101996, Depuy (Ireland)
- Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, K992065, Depuy Orthopaedics, Inc.
- Aequalis™ Ascend™ Flex Shoulder System, K122698, Tornier SAS ●
- Aequalis Universal Shoulder Glenoid, K994393, Tornier, S.A.
4
The following reference devices are cited within the submission:
- Medacta Shoulder System, K170452, Medacta International SA ●
- Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, K092265, Medacta 0 International SA
- Aequalis Shoulder Fracture System & Aequalis Shoulder System, K060209, Tornier
- Total Hip Prosthesis System Quadra S + CoCrMo Femoral Ball Head + Apricot, ● K072857, Medacta International SA
IV. Device Description
The Medacta Anatomic Shoulder Prosthesis is a modular system intended to be used for anatomical shoulder arthroplasty.
The Medacta Anatomic Shoulder Prosthesis is composed of the following components:
- . Standard Humeral Diaphysis - Cementless (sizes 6 to 16)
- Standard Humeral Diaphysis Cemented (sizes 6 to 16) ●
- Humeral Anatomical Metaphysis Cementless (128°, 135° and 142° inclinations, sizes 6 ● to 16)
- Humeral Anatomical Metaphysis Cemented (128°, 135° and 142° inclinations, sizes 6 to ● 16)
- Double Eccenter ●
- Cobalt-Chromium Humeral Head (10 sizes, Ø 40 mm to Ø 58 mm) ●
- Highcross PE Pegged Glenoid (10 sizes, Ø 40 mm to Ø 58 mm)
- Humeral Stem Screw o
The Standard Humeral Diaphysis and the Humeral Anatomical Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Humeral Stem Screw. The Double Eccenter is also connected to the Humeral Anatomical Metaphysis by means of a press-fit cylinder and a securing screw. The Cobalt-Chromium Humeral Head is coupled to a Double Eccenter by means of a taper Morse connection.
The Glenoid Anatomical Implant is composed of the Highcross PE Pegged Glenoid only, which is cemented into the glenoid bone.
The Medacta Anatomic Shoulder Prosthesis components are single-use only, are provided sterile via gamma irradiation or ethylene oxide, and are packaged individually.
The standard humeral diaphysis, humeral anatomical metaphysis, double eccenter, and humeral stem screw are manufactured from titanium alloy. The humeral head is manufactured from CoCr, and the highcross glenoid is manufactured from polyethylene.
5
V. Indications for Use
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
VI. Comparison of Technological Characteristics
The Medacta Anatomic Shoulder Prosthesis and the predicate devices share the following characteristics:
- Indications for Use ●
- Components ●
- Size ●
- Materials
- Design ●
- Coating ●
The Medacta Anatomic Shoulder Prosthesis is technologically different from the predicate devices as follows:
- Surface treatment of the cementless components
Discussion
As seen above, the technological difference between the subject and predicate device does not raise different questions of safety or effectiveness and performance data submitted within this 510(k) supports this difference.
6
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
- Coating characterization studies ●
- o Metallographic, SEM, and XRD analyses
- Mechanical Testing
- o Fatigue Testing in accordance with:
- ASTM F1378-12 Standard Specification for Shoulder Prosthesis ■
- ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery - Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including Amendment 1 (2016)]
- Wear Testing in accordance with: o
- ASTM F1378-12 Standard Specification for Shoulder Prosthesis ■
- 트 ASTM F2028-14 Standard Test Methods For Dynamic Evaluation Of Glenoid Loosening Or Disassociation Prostheses
- ISO 14242-1:2002 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for weartesting machines and corresponding environmental conditions for test
- ISO 14242-2:2000 Implants for surgery – Wear of total hip-joint prostheses - Part 2: Methods of measurement
- 트 ISO 17853:2011 Wear of implants materials -- Polymer and metal wear particles -- Isolation and characterization
- Range of Motion Analysis O
- Micromotion Assessment in accordance with: O
- ASTM F2028-14 Standard Test Methods For Dynamic Evaluation Of ■ Glenoid Loosening Or Disassociation Prostheses
- . ASTM F1839-08 (Reapproved 2012) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- ASTM F1378-12 Standard Specification for Shoulder Prosthesis
- o Axial Disassembly Testing in accordance with
- ASTM F2009-00 (Reapproved 2011) Standard Test Method for . Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- ASTM F1378-12 Standard Specification for Shoulder Prosthesis 트
- o Fatigue Testing in accordance with:
- Cadaver Testing ●
7
- Sterilization Validation in accordance with: ●
- 0 AAMI/ANSI/ISO 11137-1:2006 (R2015) Sterilization of Healthcare Products -Radiation - Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
- AMI/ANSI/ISO 11137-2:2013 Sterilization of Healthcare Products Radiation o - Part 2: Establishing the Sterilization Dose
- AAMI/ANSI/ISO 11135:2014 Sterilization Of Health Care Products Ethylene o Oxide - Requirements For Development, Validation And Routine Control Of A Sterilization Process for Medical Devices
- Ethylene Oxide Residuals in accordance with: ●
- 0 AAMI/ANSI/ISO 10993-7:2008(R)2012 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- Bacterial Endotoxin Testing (LAL Method)
- Packaging validation in accordance with:
- ISO 11607-1 First Edition 2006-04-15 Packaging For Terminally Sterilized O Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- o ISO 11607-2 First Edition 2006-04-15 Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes [Including: Amendment 1 (2014)]
- Shelf-life studies in accordance with: 0
- ISO 11607-1 First Edition 2006-04-15 Packaging For Terminally Sterilized o Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier o Systems for Medical Devices
VIII. Conclusion
The information provided above supports that the Medacta Anatomic Shoulder Prosthesis is as safe and effective as the predicate devices. Although there is a minor difference in surface treatment between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Medacta Anatomic Shoulder Prosthesis is substantially equivalent to the predicate devices.