COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY

K113069 · Biomet Manufacturing Corp · PHX · Jan 11, 2012 · Orthopedic

Device Facts

• Record ID: K113069
• Device Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Jan 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseblate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Story

Reverse shoulder prosthesis; replaces traditional shoulder joint with ball on glenoid side and polyethylene bearing on humeral side. Configuration increases deltoid muscle lever arm to provide stability and arm elevation in patients with non-functioning rotator cuffs. Implanted by orthopedic surgeons in clinical settings. Device components include humeral tray, humeral bearing, glenoid baseplate, glenoid screws, and glenosphere. Provides mechanical support and joint articulation to restore function and reduce pain.

Clinical Evidence

No clinical data submitted. Substantial equivalence determined via non-clinical mechanical testing.

Technological Characteristics

Materials: Ti-6Al-4V, Co-Cr-Mo, UHMWPE (ArComXL®, 1020 E-Poly™). Components: Humeral tray, humeral bearing, glenoid baseplate, glenoid screws, glenosphere. Fixation: Cemented, press-fit, or uncemented biological fixation (HA/porous coating). Polyethylene properties meet ASTM F-648. Semi-constrained design.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy or failed shoulder replacement. Requires anatomically suitable structure and functional deltoid muscle. Used for primary, fracture, or revision total shoulder replacement to relieve pain and disability.

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

• Comprehensive® Reverse Shoulder (K080642)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581-0857

Re: K113069

Trade/Device Name: Comprehensive® Reverse Shoulder Humeral Tray Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: October 13, 2011 Received: October 17, 2011

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of January 11, 2012.

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

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### Page 2 - Ms. Patricia Sandborn Beres

device-related 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 [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" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -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): KI (3009

Device Name: Comprehensive® Reverse Shoulder Humeral Tray

Indications For Use:

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseblate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth PM

Soc (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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113069

MANUFACTURING CORP.

-- J

## 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| SUBMITTER INFORMATION | | |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell Drive<br>Warsaw, IN 46581-0857 | |
| Phone number | (574):267-6639 | |
| Fax number | (574):371-1027 | |
| Establishment Registration<br>Number | 1825034 | |
| Name of contact person | Patricia Sandborn Beres<br>Senior Regulatory Specialist<br>Biomet Manufacturing Corp. | |
| Date prepared | October 13, 2011 | |
| NAME OF DEVICE | | |
| Trade or proprietary<br>name | Comprehensive® Reverse Shoulder Humeral Tray | |
| Common or usual name | Shoulder Prosthesis | |
| Classification name | Shoulder joint, metal/polymer, semi-constrained; cemented prosthesis | |
| Classification panel. | Orthopedics | |
| Regulation | 21 CFR 888.3660 | |
| Product Code(s) | KWS | |
| Legally marketed device(s) to<br>which equivalence is claimed | Comprehensive® Reverse Shoulder<br>510(k) K080642 | |
| Reason for 510(k) submission | Product improvement | |
| Device description | The Comprehensive® Reverse Shoulder is intended for total shoulder<br>replacement in a reverse shoulder configuration. Unlike traditional total<br>shoulder replacement, a reverse shoulder employs a ball for articulation<br>on the glenoid side of the joint and a polyethylene bearing surface on<br>the humeral side of the joint. This device configuration increases the<br>lever arm of the deltoid muscle bundle to provide stability and the ability<br>to raise the arm. This is especially useful in cases where a patient has a<br>non-functioning rotator cuff which severely limits traditional joint<br>replacement options. | |
| Intended use of the device | Shoulder Replacement | |
| Indications for use | The Comprehensive® Reverse Shoulder is indicated for use in patients<br>whose shoulder joint has a grossly deficient rotator cuff with severe<br>arthropathy and/or previously failed shoulder joint replacement with a<br>grossly deficient rotator cuff. The patient must be anatomically and<br>structurally suited to receive the implants and a functional deltoid<br>muscle is necessary.<br><br>The Comprehensive® Reverse Shoulder is indicated for primary,<br>fracture, or revision total shoulder replacement for the relief of pain.<br>and significant disability due to gross rotator cuff deficiency. | |
| Indications for use.<br>(continued) | Glenoid components with Hydroxyapatite (HA) coating applied over the<br>porous coating are indicated only for uncemented biological fixation<br>applications. The Glenoid Baseplate components are intended for<br>cementless application with the addition of screw fixation.<br>Interlok® finish humeral stems are intended for cemented use and the<br>MacroBond® coated humeral stems are intended for press-fit or<br>cemented applications. Humeral components with porous coated<br>surface coating are indicated for either cemented or uncemented<br>biological fixation applications. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | | |
| PREDICATE | | |
| Characteristic | Modified Device | Comprehensive® Reverse Shoulder<br>510(k) K080642 |
| Humeral Tray | Sizes: 44mm (std, +5mm, +10mm)<br>Finish: No change.<br>Material: Ti-6Al-4V and Co-Cr-Mo<br>Attachment: No change<br>Angle: No change | Sizes: 44 & 49mm (std, +5mm, +10mm)<br>Finish: Smooth<br>Material: Ti-6Al-4V<br>Attachment: Taper<br>Angle: 45° |
| Humeral Bearing | No Changes | UHMWPE:(ArComXL®, 1020 E-Poly™)<br>31, 36, 41mm<br>Std, Std +3mm, Retentive:+3mm<br>Ringloc® snap ring |
| Glenoid.Baseplate | No Changes | Diameter: 28mm<br>Surface Finish: PPS/HA<br>Material: Ti-6Al-4V<br>Fixation: Screws |
| Glenoid Screws | Styles: Fixed/Locking, Fixed Non-<br>Locking<br>Material: No change<br>Diameter: No change<br>Lengths: No change<br>Drive Slot: 2.5 Hex | Styles: Fixed/Locking, Fixed Non-Locking,<br>Variable Locking<br>Material: Ti-6Al-4V<br>Diameter: 4.75mm<br>Lengths: 15-45mm<br>Drive Slot: Hexalobular |
| Glenosphere | No Changes | Diameters: 31, 36, 41mm,<br>Offset: Std, +3mm, +6mm<br>Material. Co-Cr-Mo<br>Attachment to Base: Taper |
| PERFORMANCE DATA | | |
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results:Summary |
| Fatigue Strength | None | The median fatigue strength was<br>greater for the modified devices<br>compared to the predicate device. |
| Polyethylene Properties | ASTM F-648 | All properties exceed the<br>requirements of ASTM F-648 |
| Summary of clinical tests conducted for determination of substantial equivalence and/or of<br>clinical information | | |
| No clinical data submitted | | |

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KH3069

#### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

No clinical data was necessary for a determination of substantial'equivalence.

The results of mechanical testing indicated the device performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

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