Delta Xtend Reverse Shoulder System

K183077 · Depuy(Ireland) · PHX · May 17, 2019 · Orthopedic

Device Facts

• Record ID: K183077
• Device Name: Delta Xtend Reverse Shoulder System
• Applicant: Depuy(Ireland)
• Product Code: PHX · Orthopedic
• Decision Date: May 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or; · a previously failed joint replacement and/or: · fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory 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. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

Device Story

Delta Xtend Reverse Shoulder System is a semi-constrained shoulder prosthesis; used for total or hemi-shoulder arthroplasty. Subject device adds lateralized glenosphere components to existing system. System components include humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene, and metaglene screws. Operates by replacing damaged joint surfaces; restores shoulder function in patients with non-functional rotator cuffs. Used in clinical/surgical settings by orthopedic surgeons. Lateralized glenosphere design allows for increased range of motion compared to non-lateralized versions. Output is a reconstructed joint structure; aids in pain relief and functional restoration for patients with severe shoulder pathology.

Clinical Evidence

Bench testing only. Biocompatibility confirmed per ISO 10993-1. Theoretical simulated range of motion analyses showed increased range of motion compared to non-lateralized predicate. Glenoid loosening/disassociation study demonstrated substantial equivalency of fixation performance.

Technological Characteristics

Materials: CoCrMo alloy (glenosphere body), Titanium alloy (fixation component). Design: Lateralized glenosphere (0, 2, 4, 6, 8mm options), 38/42mm sizes, centered/eccentric sphere. Fixation: Taper lock and screw. Sterilization: Gamma radiation, single use. Shelf life: 5 years.

Indications for Use

Indicated for patients with grossly deficient rotator cuff, severe arthropathy, failed joint replacement, or proximal humerus fracture-dislocations. Requires functional deltoid muscle and anatomically suitable joint. Also indicated for hemi-arthroplasty if glenoid fractured intraoperatively or for revision of failed Delta Xtend Reverse Shoulder.

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, K120174)
• Aequalis Reversed Prosthesis (K030941, K061439, K081059, K140478, K151293)

Submission Summary (Full Text)

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May 17, 2019

DePuy (Ireland) % Yayoi Fujimaki Regulatory Affairs Project Manager DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582

Re: K183077

Trade/Device Name: Delta Xtend™ Reverse 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, KWS, HSD Dated: April 17, 2019 Received: April 18, 2019

Dear Yayoi Fujimaki:

This letter corrects our substantially equivalent letter of May 17, 2019.

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR CAPT Raquel Peat, PhD, MPH, USPHS Director DHT6A: Division of Joint Arthroplasty Devices OHT 6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K183077

Device Name

DELTA XTEND Reverse Shoulder System

Indications for Use (Describe)

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or;

· a previously failed joint replacement and/or:

· fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory

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.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use.

All other metallic components are intended for cemented use only.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

As required by 21 CFR 807.92 and 21 CFR 807.93

| Submission Information | | |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Sponsor Name | DePuy (Ireland) | |
| Sponsor Address | Loughbeg, Ringaskiddy Co. Cork Ireland | |
| Sponsor Establishment<br>Registration Number | 9616671 | |
| 510(k) Contact | Yayoi Fujimaki<br>DePuy Synthes<br>Regulatory Project Manager | Phone: [phone]<br>Email: [e-mail] |
| Date prepared | November 2, 2018 | |
| Device Information | | |
| Trade or proprietary name | DELTA XTEND™ Reverse Shoulder System | |
| Common or usual name | Shoulder Prosthesis | |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented prosthesis | |
| Class, regulation | Class II, 21 CFR 888.3660 | |
| Product Code | PHX, KWS, HSD | |
| Classification panel | Orthopedics panel | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | DELTA XTEND Reverse Shoulder System (DePuy: K062250,<br>K120174),<br>Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439,<br>K081059, K140478, K151293) | |
| Reason for 510(k)<br>submission | Addition of lateralized glenosphere components to the Delta Xtend<br>Reverse Shoulder System | |
| Device description | The Delta Xtend Reverse Shoulder System consists of humeral<br>stem, modular epiphysis, humeral spacer, humeral cup,<br>glenosphere, metaglene and metaglene screws. The glenosphere and<br>metaglene are used for total reverse shoulder arthroplasty. The<br>humeral spacer can be added between the epiphysis and the<br>humeral cup if necessary. Humeral head can be used in hemi-<br>shoulder arthroplasty in place of the humeral cup and glenoid<br>components. | |
| Intended use of the device | The Delta Xtend Reverse Shoulder prosthesis is intended for use in<br>total or hemi-shoulder arthroplasty procedures in patients with non-<br>functional rotator cuffs, with or without bone cement. | |
| Indications for use | The Delta Xtend Shoulder Prosthesis is indicated for use in<br>treatment of a grossly deficient rotator cuff joint with:<br>severe arthropathy and/or; a previously failed joint replacement and/or: fracture-dislocations of the proximal humerus where the | |
| | articular surface is severely comminuted, separated from its | |
| | blood supply or where the surgeon's experience indicates that | |
| | alternative methods of treatment are unsatisfactory | |
| | 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. | |
| | Delta Xtend hemi-shoulder replacement is also indicated for hemi- | |
| | arthroplasty if the glenoid is fractured intraoperatively or for the | |
| | revision of a previously failed Delta Xtend Reverse Shoulder. | |
| | The metaglene component is HA coated and is intended for | |
| | cementless use with the addition of screws for fixation. | |
| | The modular humeral stem and humeral epiphysis components are | |
| | HA coated and intended for cementless use. All other metallic | |
| | components are intended for cemented use only. | |
| Testing Data | | |
| Summary of non-clinical<br>study | Biocompatibility was confirmed per ISO10993-1. Theoretical<br>simulated range of motion analyses showed increase of range of<br>motion compared to the predicate non-lateralized glenosphere.<br>Glenoid loosening/disassociation study demonstrated substantial<br>equivalency of glenoid fixation performance to the predicate. | |
| Summary of animal study | Animal study was not necessary. | |
| Summary of clinical study | Clinical study was not necessary. | |
| Conclusion | Substantial equivalency to the predicate devices can be<br>demonstrated on following grounds:<br>- the subject lateralized glenosphere has the same intended use as<br>the predicate glenosphere of the Delta Xtend Reverse shoulder<br>system and the Aequalis Reversed Shoulder Prosthesis.<br>- the subject lateralized glenosphere's technological<br>characteristics are equivalent to the predicate Aequalis<br>Reversed Shoulder Prosthesis glenosphere.<br>- different technological characteristic between the subject and<br>the predicate Delta Xtend Reverse Shoulder System is<br>glenosphere lateralization. Addition of the lateralized<br>glenosphere does not change the intended use, indications,<br>principle of operation or surgical procedure. No new question<br>is raised. Performance study demonstrated substantial<br>equivalency to the predicate.<br>Therefore, the subject Delta Xtend lateralized glenosphere is<br>substantially equivalent to the predicate Delta Xtend Reverse<br>shoulder system. The design, intended use, and materials are also<br>equivalent to the Tornier Aequalis Reversed Shoulder Prosthesis | |

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## (K151293, K140478, K081059, K061439, K030941).

| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE | | |
|------------------------------------------------------------|-------------------------------------|--------------------------------|
| COMPARED TO THE PREDICATE DEVICES | | |
| Device | Subject Device: | Predicate: Delta Xtend Reverse |
| | Delta Xtend Reverse Shoulder System | Shoulder System |
| | Lateralized glenosphere | Glenosphere |
| 510(k)# | This submission | K062250, K120174 |
| | (DePuy) | (DePuy) |
| Intended Use | Reverse Shoulder Arthroplasty | Reverse Shoulder Arthroplasty |
| Glenosphere Material | | |
| Body | CoCrMo alloy | CoCrMo alloy |
| Fixation component | Titanium alloy | Titanium alloy |
| Glenosphere Design | | |
| Sizes | 38, 42mm | 38, 42mm |
| Sphere | Centered, eccentric (2mm) | Centered, eccentric (2mm) |
| Lateralization | 0, 2, 4, 6, 8mm | 0mm |
| Fixation with base | Taper lock and screw | Taper lock and screw |
| plate | | |
| Others | | |
| Sterilization | Gamma, single use | Gamma, single use |
| Shelf Life | 5 years | 5 years |