(59 days)
No
The 510(k) summary describes a mechanical orthopedic implant (shoulder prosthesis components) and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a medical implant used to treat humeral fractures and for primary or revision total shoulder replacement, which are clear therapeutic interventions.
No
Explanation: The device described is a shoulder prosthesis, which is an implant used for treatment of humeral fractures and primary or revision total shoulder replacement, not for diagnostic purposes.
No
The device description clearly outlines various physical components made of Ti alloy, such as the Humeral Eccentric Reverse Metaphysis, screws, and other parts of the Medacta Shoulder Reverse System. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating shoulder conditions like fractures and severe arthropathy. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a prosthesis component (Humeral Eccentric Reverse Metaphysis) made of titanium alloy, designed to be surgically implanted. This is consistent with a medical device for treatment, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
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 cuffshoulder 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 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 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 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, KWS, MBF
Device Description
The Humeral Eccentric Reverse Metaphysis is a line extension to the Medacta Shoulder Reverse System (K170452) and it is compatible with the other Medacta cleared products: Humeral Reverse PE Liner (K170452), Humeral Diaphysis (K170452), Short Humeral Diaphysis (K180089), Long Humeral Diaphysis (K192967).
The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.
The Humeral Eccentric Reverse Metaphysis implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:
- Humeral Diaphysis Cemented; ●
- Humeral Diaphysis Cementless; ●
- Humeral Reverse Metaphysis; ●
- Humeral Reverse HC Liner (also referred to as PE Liner); ●
- Glenoid Baseplate - Pegged;
- Glenoid Baseplate - Threaded;
- . Glenosphere;
- . Lateralized Glenosphere
- Glenoid Polyaxial Locking Screw;
- Glenoid Polyaxial Non-Locking Screw; ●
- Reverse Metaphysis Screw; and ●
- Glenosphere Screw.
The Humeral Diaphysis and the Humeral Reverse Metaphysis (standard or eccentric) are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis (standard or eccentric).
The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.
The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.
The screw of the Reverse Metaphysis (standard or eccentric), packaged with main body, is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy, enhanced with Type-II anodization.
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:
- Characterization Tests
- Design Validation Report.
- Performance Tests
- Static Torsion test
- Rationale, Humeral Eccentric Reverse Metaphysis Worst Case Assessment.
- Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
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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Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 83118
Re: K210207
Trade/Device Name: Humeral Eccentric Reverse Metaphysis 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: January 25, 2021 Received: January 26, 2021
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 (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 located 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.
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
March 26, 2021
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Michael Owens 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
2
Indications for Use
510(k) Number (if known) K210207
Device Name
Humeral Eccentric Reverse Metaphysis
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 cuffshoulder 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 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 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 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.
| 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
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 Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality and Regulatory, Medacta USA Date Prepared: January 25, 2021 Date Revised: March 26, 2021
II. Device
| Device Proprietary Name: | Humeral Eccentric Reverse Metaphysis |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis, Reverse Configuration |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Primary Product Code: | PHX |
| Secondary Product Code: | KWS , MBF |
| Regulation Number: | 21 CFR 888.3660 and 21 CFR 888.3670 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
-
Primary Predicate:
- · Humeral reverse metaphysis (Medacta Shoulder Reverse System), K170452, Medacta International SA;
> Reference Device:
- · Delta Xtend™ Reverse Shoulder System, K120174, DePuy Orthopaedics, Inc.
- · Short Humeral Stem, K180089, Medacta International
- · Medacta Shoulder System Long Stem Shoulder, K192967, Medacta International
4
Device Description IV.
The Humeral Eccentric Reverse Metaphysis is a line extension to the Medacta Shoulder Reverse System (K170452) and it is compatible with the other Medacta cleared products: Humeral Reverse PE Liner (K170452), Humeral Diaphysis (K170452), Short Humeral Diaphysis (K180089), Long Humeral Diaphysis (K192967).
The Humeral Eccentric Reverse Metaphysis implant subject of this submission is comprised of the following size: Diameter= Ø37.5mm Offset= 3mm.
The Humeral Eccentric Reverse Metaphysis implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:
- Humeral Diaphysis Cemented; ●
- Humeral Diaphysis Cementless; ●
- Humeral Reverse Metaphysis; ●
- Humeral Reverse HC Liner (also referred to as PE Liner); ●
- Glenoid Baseplate - Pegged;
- Glenoid Baseplate - Threaded;
- . Glenosphere;
- . Lateralized Glenosphere
- Glenoid Polyaxial Locking Screw;
- Glenoid Polyaxial Non-Locking Screw; ●
- Reverse Metaphysis Screw; and ●
- Glenosphere Screw.
The Humeral Diaphysis and the Humeral Reverse Metaphysis (standard or eccentric) are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis (standard or eccentric).
The purpose of the current submission is to gain clearance for the Humeral Eccentric Reverse Metaphysis.
The main body of Humeral Eccentric Reverse Metaphysis is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.
The screw of the Reverse Metaphysis (standard or eccentric), packaged with main body, is made of Ti alloy (Ti-6A1-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy, enhanced with Type-II anodization.
5
The Humeral Eccentric Reverse Metaphysis, implant is substantially equivalent to Medacta predicate device Humeral reverse metaphysis (K170452) and to competitor predicate device Delta Xtend™ Reverse Shoulder System, (K120174) Depuy Orthopaedics, Inc.
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 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.
VI. Comparison of Technological Characteristics
The Humeral Eccentric Reverse Metaphysis and the main predicate device Humeral reverse metaphysis (cleared within Medacta Shoulder Reverse System) K170452. Medacta International SA share the following characteristics:
- indications for use; ●
- substrate material (Ti6Al4V): ●
- Humeral reverse construct: ●
- diameter:
- . humeral reverse HC liner - Inclination
- biocompatibility:
- device usage:
- sterility: ●
- . shelf life; and
- packaging. .
The Humeral Eccentric Reverse Metaphysis is technologically different from the main predicate device as follows:
- Connection between Metaphysis and Diaphysis (there is no reverse indexing pin) ●
- Numbers of Evelets ●
6
- . Coating (there is no coating)
- . Size range
The subject Humeral Eccentric Reverse Metaphysis has the same technological characteristics of the Medacta predicate device Humeral Reverse Metaphysis (cleared within Medacta Shoulder Reverse System) K170452, with the only exception of the offset between Metaphysis and Diaphysis, feature shared with the other predicate Delta Xtend™ Reverse Shoulder System, K120174, DePuy Orthopaedics, Inc.
The biocompatibility of the Humeral Eccentric Reverse Metaphysis was evaluated based on using identical materials and manufacturing processes as a previously cleared device. The subject and predicate devices are manufactured from the following material: Ti alloy (Ti-6AI-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.
While the screw of the Reverse Metaphysis (standard or eccentric), packed with the main body is made of Ti alloy (Ti-6Al-4V), according to ISO 5832-3:2016 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy enhanced with Type-II anodization.
Performance Data VII.
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in substantial equivalence determination:
Non-Clinical Studies:
- Characterization Tests ●
- o Design Validation Report.
- Performance Tests ●
- Static Torsion test o
- Rationale, Humeral Eccentric Reverse Metaphysis Worst Case Assessment. o
- Pyrogenicity ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
Based on the above information, the Humeral Eccentric Reverse Metaphysis is substantially equivalent to the identified predicate devices.
7
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The Humeral Eccentric Reverse Metaphysis implants are substantially equivalent to the predicate devices Medacta Humeral Reverse Metaphysis cleared under Medacta Shoulder Reverse System K170452 (predicate device).