Medacta Shoulder System

K170452 · Medacta International S.A. · PHX · Oct 5, 2017 · Orthopedic

Device Facts

• Record ID: K170452
• Device Name: Medacta Shoulder System
• Applicant: Medacta International S.A.
• Product Code: PHX · Orthopedic
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

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 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 for the device to offer full function in vivo. The glenoid baseplate is intended for cementless application of screws for primary stability.

Device Story

The Medacta Shoulder System is a modular reverse shoulder prosthesis used for total shoulder arthroplasty. It consists of a humeral diaphysis (cemented or cementless), humeral reverse metaphysis, humeral reverse HC (polyethylene) liner, glenoid baseplate, glenoidsphere, and various locking screws. Components are assembled via cylindrical driven-fit, taper Morse connections, and embedded clipping mechanisms. The device is implanted by orthopedic surgeons in a clinical/surgical setting. It replaces the damaged shoulder joint to restore function in patients with rotator cuff deficiency. The system provides structural support and articulation, with the glenoid baseplate fixed via screws for primary stability. Clinical benefit includes pain relief and restoration of shoulder function.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench testing, including wear testing (ASTM F1378-12), fatigue testing (ASTM F1378-12, ASTM F543-13), micromotion assessment (ASTM F2028-14), and coating characterization (ASTM F2024-10).

Technological Characteristics

Modular shoulder prosthesis. Materials: Ti6-Al-4V (ISO 5832-3), Ti6-Al-7Nb (ISO 5832-11), Co-Cr-Mo (ISO 5832-12), and UHMWPE. Coatings: Titanium (ASTM F1580) and Hydroxyapatite (ASTM F1185). Fixation: Cemented or cementless with polyaxial locking screws. Sterilization: Gamma and EO. Design features include taper Morse connections and embedded clipping mechanisms.

Indications for Use

Indicated for patients with humeral fractures, or primary/revision total shoulder replacement requiring reverse shoulder arthroplasty. Patient population includes those with severe arthropathy and a grossly deficient rotator cuff, or failed prior joint replacement with a grossly deficient rotator cuff. Requires anatomically suitable joint and functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Delta Xtend™ Reverse Shoulder System (K062250)
• Delta Xtend™ Reverse Shoulder Modular Stem (K071379)
• Comprehensive® RS Shoulder System (K072804)
• Synthes Epoca Shoulder Prosthesis System (K083439)
• Aequalis Shoulder Fracture System & Aequalis Shoulder System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis (K112144)

Reference Devices

• Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners (K092265)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

Medacta International Sa % Elizabeth Rose Manager, Regulatory Affairs Mapi Usa. Inc. 2343 Alexandria Drive Suite 100 Lexington, Kentucky 40504

October 5, 2017

Re: K170452

Trade/Device Name: Medacta Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, HSD, MBF Dated: September 7, 2017 Received: September 8, 2017

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);

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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 (DICE) at its toll-free number [phone] or [phone] 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 (DICE) at its toll-free number [phone] or [phone] 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

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### Indications for Use

510(k) Number (if known) K170452

Device Name Medacta Shoulder System

#### 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 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 for the device to offer full function in vivo.

The glenoid baseplate is intended for cementless application of screws for primary stability.

| 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)

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## 3.0 510(k) Summary

#### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

Contact Person: Stefano Baj, Regulatory Affairs Manager Date Prepared: February 14, 2017 Date Revised: September 07, 2017

| Device Proprietary Name: | Medacta Shoulder System |
|--------------------------|-----------------------------------------------------------------------|
| Common or Usual Name: | Shoulder Prosthesis, Reverse Configuratin |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis. |
| Primary Product Code: | PHX |
| Secondary Product Code: | HSD, MBF |
| Regulation Number: | 21 CFR 888.3660, 21 CFR 888.3690, 21CFR 888.3670 |
| Device Classification | 2 |

#### TT Device

#### III. Predicate Device

Substantial equivalence is claimed to the following devices: Primary Predicate:

- Delta Xtend™ Reverse Shoulder System, K062250, DePuy Orthopaedics, Inc. ●
- Delta Xtend™ Reverse Shoulder Modular Stem, K071379, DePuy Orthopaedics, Inc. ●

### Additional Predicates

- Comprehensive® RS Shoulder System, K072804, Biomet Manufacturing Corporation ●
- Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA) ●
- Aequalis Shoulder Fracture System & Aequalis Shoulder System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis (also referred to as Aequalis Reversed II), K112144, Tornier

Reference Device

- Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, K092265, Medacta ● International, SA

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Medacta International SA

Medacta Shoulder System Traditional 510(k)

#### IV. Device Description

The purpose of this submission is to gain clearance for the new Medacta Shoulder System. The Medacta Shoulder System is a modular system intended to be used for Reverse Shoulder Arthroplastises (RSA). The Medacta Shoulder System is composed of the following components:

- Humeral Diaphysis Cemented .
- 트 Humeral Diaphysis - Cementless
- Humeral Reverse Metaphysis
- Humeral Reverse HC Liner (also referred to as PE Liner) ■
- Glenoid Baseplate
- Glenoidsphere
- Glenoid Polyaxial Locking Screws
- Reverse Metaphysis Screw
- Glenoidsphere Screw

The Humeral Diaphysis and Humeral Reverse Metaphysis 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.

The Glenoid Baseplate is intended to be fixed on the glenoid bone by means of a central press-fit and with the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with the Glenoid Baseplate by means of a taper Morse connection and secured by the Glenoidsphere Screw.

The Glenoidsphere Screw, Reverse Metaphysis Screw, and Glenoid Polyaxial Locking Screws are made of Ti alloy enhanced with Type-II anodization.

The Medacta Shoulder System is similar to the predicate devices DePuy Delta Xtend™ (K062250 and K071379), Biomet Comprehensive® RS Shoulder System (K072804) and Tornier Aequalis Reversed II (K112144).

#### 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.

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The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

#### VI. Comparison of Technological Characteristics

The Medacta Shoulder System and the predicate devices share the following characteristics:

- indications for use;
- materials:
- design:
- sterile:
- coating;
- thread design; and ●
- device usage

The Medacta Shoulder System is technologically different from the predicate devices as follows:

- sizes:
- lengths; and ●
- diameters ●

Biocompatibility testing conducted on the predicate devices for the same or similar materials supports the biological safety of the Medacta Shoulder System. The Medacta Shoulder System components are manufactured from the following materials:

- Titanium Alloy (Ti6-A1 4-V) ISO 5832-3:1996 Implants For Surgery Metallic O Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy
- Titanium Alloy (Ti6-A1 7-Nb) ISO 5832-11 Second Edition 2014-09-15: Implants For O Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy
- Cobalt-Chromium-Molybdenum alloy (Co-Cr-Mo) per ISO 5832-12 Second Edition o 2007-05-01: Implants For Surgery-- Metallic Materials -- Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy [Including: Technical Corrigedum 1 (2008)]
- Ultra High Molecular Weight Polyethylene (UHMWPE) Highcross O

These materials have an extensive amount of biocompatibility data that has been provided in the listed predicate devices' 510(k) submissions DePuy Delta Xtend™ (K062250 and K071379), Biomet Comprehensive® RS Shoulder System (K072804) and Tornier Aequalis Reversed II (K112144), as well as the UHMWPE Highcross reviewed in reference device Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners (K092265).

The Titanium Y367 + Hydroxyapatite "Osprovit®" coating used on the Medacta Shoulder System - Humeral Diaphysis Cementless component is provided by Eurocoating S.p.A. The Hydroxyapatite "Osprovit®" coating used on the Medacta Shoulder System - Humeral Reverse Metaphysis and Glenoid Baseplate components is provided by Eurocoating S.p.A.

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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<br>Shoulder System<br>(Subject Device) | DePuy Delta<br>Xtend™<br>K062250 and<br>K071379<br>(Predicate<br>Device) | Biomet<br>Comprehensive®<br>RS Shoulder<br>System K072804<br>(Predicate<br>Device) | Tornier<br>Aequalis<br>Reversed II<br>K112144<br>(Predicate<br>Device) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium Alloy,<br>Cobalt<br>Chromium,<br>UHMWPE | Titanium Alloy,<br>Cobalt<br>Chromium,<br>UHMWPE | Titanium Alloy,<br>Cobalt<br>Chromium,<br>UHMWPE | Titanium Alloy,<br>Cobalt<br>Chromium,<br>UHMWPE |
| Coating | Titanium<br>(ASTM F1580)<br>Hydroxyapatite<br>(ASTM F1185) | Hydroxyapatite<br>(ASTM F1185) | Titanium<br>(ASTM F1580)<br>Hydroxyapatite<br>(ASTM F1185) | Titanium<br>(ASTM F1580)<br>Hydroxyapatite<br>(ASTM F1185) |
| Bone Cement | Cemented/<br>Cementless | Cemented/<br>Cementless | Cemented/<br>Cementless | Cemented/<br>Cementless |
| System<br>Components | STD Humeral<br>Diapyhsis<br>(Cementless/Cem<br>ented), Humeral<br>Reverse<br>Metaphysis,<br>Humeral Reverse<br>HC Liner,<br>Glenoid<br>Baseplate,<br>Glenoid Polyaxial<br>Locking Screw,<br>Glenoidsphere | STD Humeral<br>Diapyhsis<br>(Cementless/Cem<br>ented), Humeral<br>Reverse<br>Metaphysis,<br>Humeral Reverse<br>Liner, Glenoid<br>Baseplate,<br>Glenoid Polyaxial<br>Locking Screw,<br>Glenoidsphere | STD Humeral<br>Diapyhsis<br>(Cementless/Cem<br>ented), Humeral<br>Reverse<br>Metaphysis,<br>Humeral Reverse<br>Liner, Glenoid<br>Baseplate,<br>Glenoid Polyaxial<br>Locking Screw,<br>Glenoidsphere | STD Humeral<br>Diapyhsis<br>(Cementless/Cem<br>ented), Humeral<br>Reverse<br>Metaphysis,<br>Humeral Reverse<br>Liner, Glenoid<br>Baseplate,<br>Glenoid Polyaxial<br>Locking Screw,<br>Glenoidsphere |
| Device usage | Single Use | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with<br>permanent >30<br>day<br>(Equivalency<br>determined) | Implant with<br>permanent >30<br>day | Implant with<br>permanent >30<br>day | Implant with<br>permanent >30<br>day |
| Sterilization | Gamma and EO | Gamma and EO | Gamma and EO | Gamma and EO |

Technological comparison

### 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 is the same or

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similar to the predicate devices in terms of intended use, materials of construction, design, coating, thread design, device usage, 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 to the identified predicate devices.

#### VII. Performance Data

The following mechanical tests are being provided in support of a substantial equivalence determination. Based on the risk analysis and pre-submission submitted to review testing protocols, testing was conducted to written protocols with acceptance criteria that were based on standards.

Non-Clinical Studies

- Characterization Tests
- O Validation Cadaveric Workshop Evaluations
- ROM of the Medacta Shoulder System-RSA O
- Humeral Diaphysis Assessment of Design and Dimensions O
- Design Validation Report O
- Performance Tests
- O Wear Test: ASTM F1378-12: Standard Specification For Shoulder Prosthesis
- Fatigue Testing: ASTM F1378-12: Standard Specification For Shoulder O Prosthesis
- Static Fatigue Testing: ASTM F1378-12: Standard Specification For Shoulder O Prosthesis
- Micromotions Assessment In Reverse Configuration: ASTM F2028-14: Standards o Test Methods For Dynamic Evaluation of Glenoid Loosening Or Disassociation Prostheses
- Static Fatigue Testing: ASTM F543-13: Standard Specification And Test O Methods For Metallic Medical Bone Screws
- Coating Tests ●
- o Humeral Reverse Metaphysis: ASTM F2024-10: Standard Practice For X-ray Diffraction Determination Of Phase Content Of Plasma-Sprayed Hydroxyapatite Coatings
- Glenoid Baseplate: ASTM F2024-10: Standard Practice For X-ray Diffraction O Determination Of Phase Content Of Plasma-Sprayed Hydroxyapatite Coatings
- Humeral Diaphysis: ASTM F2024-10: Standard Practice For X-ray Diffraction o Determination Of Phase Content Of Plasma-Sprayed Hydroxyapatite Coatings

Pyrogenicity

- . Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and the Pyrogen Test according to USP chapter <151> for pyrogenicity determination.
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or pyrogen free.

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Medacta International SA

Medacta Shoulder System Traditional 510(k)

Clinical Studies

- No clinical studies were conducted. .
### VIII. Conclusion

The information provided above supports the Medacta Shoulder System is as safe and effective as the predicate devices. Therefore, it is concluded that the Medacta Shoulder System is substantially equivalent to the predicate devices.

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