(83 days)
Not Found
No
The document describes a mechanical implant (shoulder prosthesis) and its intended use. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and material properties.
Yes
The device is a prosthesis designed to replace the shoulder joint for treatment of fractures, severe arthropathy, or failed joint replacements, which are all therapeutic interventions aimed at alleviating conditions and restoring function.
No
Explanation: The device is an implantable total shoulder replacement prosthesis, which is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an "implantable device" manufactured from "titanium alloy," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to replace parts of the shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and function of a physical implantable device. IVDs are typically reagents, kits, or instruments used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a surgical implant used for the treatment of specific shoulder conditions.
N/A
Intended Use / Indications for Use
Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy failed joint replacement with 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.
Short Humeral Diaphysis
The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy.
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.
Anatomical
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 ioint, severe arthropathy failed ioint 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.
Short Humeral Diaphysis
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy.
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 (comma separated list FDA assigned to the subject device)
PHX, KWS, MBF
Device Description
The Medacta Shoulder System Short Humeral Diaphysis is an implantable device used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared under K170910, as an alternative to the Standard Humeral Diaphysis - Cementless provided with those systems.
The Medacta Shoulder System Short Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the Humeral Anatomical Metaphysis -Cementless (K170910) in the anatomic configuration. The short humeral diaphysis implant minimizes the violation of the humeral intramedullary canal (IM).
The product is manufactured from titanium alloy (Ti6Al7Nb) and is provided sterile in 11 sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, gleno-humeral 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)
As the subject device is a line extension to previously cleared devices, verification activities, as identified through risk analysis, were conducted on the worst-case implants to written protocols with pre-defined acceptance criteria. Engineering rationales determined that the subject implants did not represent a new worst-case for mechanical testing.
The following performance tests were conducted on the predicate devices and reviewed as part of the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared under K170910 submissions:
- coating characterization studies;
- fatigue testing;
- cadaver testing;
- sterilization validation;
- packaging validation;
- shelf life; and
- pyrogenicity.
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.
Medacta Shoulder System, K170452, Aequalis Ascend Flex Shoulder System, K140082, Medacta Anatomic Shoulder Prosthesis, K170910
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.”
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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, 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 SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
April 5, 2018
Re: K180089
Trade/Device Name: Medacta Shoulder System Short Humeral Diaphysis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, MBF Dated: March 6, 2018 Received: March 6, 2018
Dear Elizabeth 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 mediation-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,
Katherine D. Kavlock -
S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180089
Device Name
Medacta Shoulder System Short Humeral Diaphysis
Indications for Use (Describe)
Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy failed joint replacement with 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.
Short Humeral Diaphysis
The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy.
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.
Anatomical
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 ioint, severe arthropathy failed ioint 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.
Short Humeral Diaphysis
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy.
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.
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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: January 12, 2018 Date Revised: March 30, 2018
II. Device
| Device Proprietary Name: | Medacta Shoulder System Short Humeral Diaphysis |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis System |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis | |
| Regulation Number: | 21 CFR 888.3660, 21 CFR 888.3670 |
| Primary Product Code: | PHX |
| Secondary Product Codes: | KWS, MBF |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate devices:
-
Medacta Shoulder System, K170452, Medacta International SA ●
Additional Predicate Devices: -
Aequalis Ascend Flex Shoulder System, K140082, Tornier SAS ●
-
Medacta Anatomic Shoulder Prosthesis, K170910, Medacta International SA
IV. Device Description
The Medacta Shoulder System Short Humeral Diaphysis is an implantable device used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared
5
under K170910, as an alternative to the Standard Humeral Diaphysis - Cementless provided with those systems.
The Medacta Shoulder System Short Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the Humeral Anatomical Metaphysis -Cementless (K170910) in the anatomic configuration. The short humeral diaphysis implant minimizes the violation of the humeral intramedullary canal (IM).
The product is manufactured from titanium alloy (Ti6Al7Nb) and is provided sterile in 11 sizes.
V. Indications for Use
Medacta Shoulder System - Reverse
Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with 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.
Short Humeral Diaphysis
The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient 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.
Medacta Shoulder System - Anatomical
Anatomical
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.
6
Short Humeral Diaphysis
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, 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 for the device to offer full function in vivo. The glenoid component is intended for cemented application.
VI. Comparison of Technological Characteristics
The Medacta Shoulder System Short Humeral Diaphysis and the predicate devices share the following characteristics:
- stem size;
- materials of construction; ●
- coating material; and
- stem shape.
The only technological characteristic difference between the Medacta Shoulder System Short Humeral Diaphysis and the predicate devices is the shorter length of the humeral diaphysis implant. Due to the reduced length of the humeral diaphysis, the length of the coated area was reduced accordingly.
VII. Performance Data
As the subject device is a line extension to previously cleared devices, verification activities, as identified through risk analysis, were conducted on the worst-case implants to written protocols with pre-defined acceptance criteria. Engineering rationales determined that the subject implants did not represent a new worst-case for mechanical testing.
The following performance tests were conducted on the predicate devices and reviewed as part of the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared under K170910 submissions:
- coating characterization studies; ●
- fatigue testing;
- cadaver testing;
- sterilization validation;
- packaging validation;
- shelf life; and ●
- pyrogenicity. ●
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VIII. Conclusion
Based on the above information, the Medacta Shoulder System Short Humeral Diaphysis can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, technological characteristics, and performance evaluations. The Medacta Shoulder System Short Humeral Diaphysis is as safe and effective as the predicate devices.