COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE

K131353 · Biomet Manufacturing Corp · PHX · Oct 8, 2013 · Orthopedic

Device Facts

• Record ID: K131353
• Device Name: COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Oct 8, 2013
• 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. Titanium glenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the Macro Bond® 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

Modular titanium alloy glenosphere prosthesis; designed as alternative to cobalt alloy components for patients with nickel/cobalt allergies. System consists of head and taper adaptor; allows variable offset (0.5mm to 4.5mm). Used with Biomet Comprehensive or BioModular Reverse Shoulder systems. Implanted by orthopedic surgeons in clinical/hospital settings to replace shoulder joint. Provides mechanical articulation for patients with severe rotator cuff deficiency. Output is physical joint replacement; aids in pain relief and restoration of function. Single-use implant.

Clinical Evidence

No clinical data submitted. Substantial equivalence determined via non-clinical bench testing, including torsional separation of tapers and pin-on-disk wear testing.

Technological Characteristics

Modular titanium alloy glenosphere prosthesis. Features variable offset taper adaptor system. Compatible with existing Biomet reverse shoulder systems. Single-use implant. Materials selected for biocompatibility in patients with cobalt alloy sensitivity.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy or failed shoulder joint replacement. Requires functional deltoid muscle and suitable anatomy. Indicated for primary, fracture, or revision total shoulder replacement for pain relief and disability due to rotator cuff deficiency. Titanium glenospheres indicated for patients with cobalt alloy sensitivity.

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, K120121)
• BioModular® Shoulder System (K030710, K093803)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 S. Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581

Re: K131353

Trade/Device Name: Comprehensive® Reverse Shoulder - Titanium Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, PAO Dated: August 27, 2013 Received: August 29, 2013

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of October 8, 2013.

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 S. 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.goy/MedicalDevices/Resourcesfor You/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): __ K131353

Device Name: Comprehensive® Reverse Shoulder - Titanium Glenosphere

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.

Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

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

Interlok® finish humeral stems are intended for cemented use and the Macro Bond® 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 × (Part 21 CFR 801 Subpart D) AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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**OCT 08 2013**

## 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 46582 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment Registration Number | 1825034 | |
| Name of contact person | Patricia S. Beres<br>Senior Regulatory Specialist<br>Biomet Manufacturing Corp. | |
| Date prepared | October 8, 2013 | |
| | NAME OF DEVICE | |
| Trade name | Comprehensive® Reverse Shoulder - Titanium<br>Glenosphere | |
| Common name | Glenosphere prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint, metal/polymer, semi-<br>constrained, cemented prosthesis | 21 CFR 888.3660 | KWS |
| Shoulder joint metal/polymer (+additive) semi-<br>constrained cemented prosthesis | 21 CFR 888.3660 | PAO |
| Classification panel | Orthopedics | |
| Legally marketed device(s) to which<br>equivalence is claimed | Comprehensive® Reverse Shoulder (K080642, K120121)<br>BioModular® Shoulder System (K030710, K093803) | |
| Reason for 510(k) submission | New device | |
| Device description | The Titanium Alloy Glenosphere Prosthesis consists<br>of a series of various sized modular glenospheres with<br>variable offset between 0.5mm and 4.5 mm. Titanium<br>alloy material has been selected to provide the<br>surgeon with an alternate material to treat patients<br>with nickel allergies. Each modular glenosphere<br>consists of a "head" and a taper adaptor. The taper<br>adaptor is impacted into the head in a certain position<br>to achieve the desired amount of offset. The system<br>can be used with Biomet's Comprehensive® Reverse<br>Shoulder System or Biomet's BioModular® Reverse<br>Shoulder System. | |

టింపిగ్రామం నుండి 100 కి.మీ. దూరంలో
గ్రామం నుండి 100 కి.మీ. దూరంలో ఉంది.
మూలాలు విద్యా సంస్థ బస్సులు గ్రామం నుండి 10 కి.మీ. దూరంలో ఉన్నాయి. వైద్యశాల సంఖ్య 2017 100000000

Shipping Address:
56 East Beil Drive Warsaw, IN 46587

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K131353 (2/2)

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510(k) Summary
Comprehensive® Reverse Shoulder – Titanium Glenosphere Page 2 of 2

| Indications<br>for use | Biomet® Comprehensive Reverse Shoulder products are indicated for use in patients<br>whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or<br>previously failed shoulder joint replacement with a grossly deficient rotator cuff. The<br>patient must be anatomically and structurally suited to receive the implants and a<br>functional deltoid muscle is necessary. |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total<br>shoulder replacement for the relief of pain and significant disability due to gross rotator<br>cuff deficiency. |
| | Titanium glenospheres are intended for patients with colbalt alloy material sensitivity. The<br>wear of these devices has not been tested but, based on pin on disk testing, the wear rate<br>is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the<br>recommended component for reverse shoulder arthroplasty patients without material<br>sensitivity to cobalt alloy. |
| | Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating<br>are indicated only for uncemented biological fixation applications. The Glenoid Baseplate<br>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<br>humeral stems are intended for press-fit or cemented applications. Humeral components<br>with porous coated surface coating are indicated for either cemented or uncemented<br>biological fixation applications. |
| | The device is a single-use implant. |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE | |
| | The number of components, sizing, and all dimensions are identical to the predicate. |

| PERFORMANCE DATA | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Torsional separation of tapers | |
| Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information | |
| No clinical data submitted | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| No clinical data was necessary for a determination of substantial equivalence. The results of testing indicate the devices 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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