COMPREHENSIVE REVERSE SHOULDER

K080642 · Biomet, Inc. · PHX · Jul 9, 2008 · Orthopedic

Device Facts

• Record ID: K080642
• Device Name: COMPREHENSIVE REVERSE SHOULDER
• Applicant: Biomet, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Jul 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

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 Baseplate components are intended for cementless application with the addition of screw fixation. Intertok® 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 for total shoulder replacement; reverses traditional anatomy by placing ball on glenoid side and polyethylene bearing on humeral side. Components include Glenoid Baseplate, Glenosphere, Humeral Tray, and Humeral Stem. Used in primary, fracture, or revision procedures to relieve pain and disability from gross rotator cuff deficiency. Implanted by orthopedic surgeons in clinical settings. Allows conversion of existing well-fixed humeral stems to reverse configuration or future conversion to hemi-shoulder. Benefits patients by restoring shoulder function when rotator cuff is deficient.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence. Non-clinical laboratory testing performed to confirm device functionality.

Technological Characteristics

Semi-constrained, cemented/uncemented shoulder prosthesis. Materials include metal and polymer. Fixation methods include cement, press-fit, and screw fixation. Features Hydroxyapatite (HA) coating, MacroBond® coating, and porous coatings for biological fixation. Modular design allows for primary, fracture, or revision configurations.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy, or failed shoulder joint replacement with gross rotator cuff deficiency. Requires anatomically/structurally suitable anatomy and functional deltoid muscle. Indicated for primary, fracture, or revision total shoulder replacement.

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® RS Shoulder (K072804)
• Anatomical Shoulder™ Inverse/Reverse (K053274)
• Equinoxe® Reverse Shoulder System (K063569, K073688)
• Encore Reverse Shoulder Prosthesis (K041066, K051075)
• Trabecular Metal™ Reverse Shoulder (K052906)

Submission Summary (Full Text)

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

November 2, 2016

Biomet. Incorporated Ms. Patricia S. Beres Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K080642

Trade/Device Name: Comprehensive® Reverse Shoulder 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: June 25, 2008 Received: June 27, 2008

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of July 9, 2008.

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

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Page 2 - Ms. Patricia S. Beres

CFR Part 807): labeling (21 CFR Part 801): medical device reporting (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); 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

Also, please note http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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): K080642

### Device Name: Comprehensive® Reverse Shoulder

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 Baseplate components are intended for cementless application with the addition of screw fixation.

Intertok® 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).

Soubare Buelur

Division of General. Restorative. and Neurological Devices

**510(k) Number** Kos50644

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JUL - 9 2008

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510(k) Summary - K080642

Preparation Date: July 7, 2008

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: Comprehensive® Reverse Shoulder

Common Name: Shoulder Prosthesis

Classification Name: Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis (21 CFR 888.3660)

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| Comprehensive® RS Shoulder | Biomet, Inc. | K072804 |
|--------------------------------------|----------------|------------------|
| Anatomical Shoulder™ Inverse/Reverse | Zimmer, Inc. | K053274 |
| Equinoxe® Reverse Shoulder System | Exactech | K063569, K073688 |
| Encore Reverse Shoulder Prosthesis | Encore Medical | K041066, K051075 |
| Trabecular Metal™ Reverse Shoulder | Zimmer, Inc. | K052906 |

Device Description: The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the ioint and a polyethylene bearing surface on the humeral side of the joint. The components may be used as a primary procedure or during the revision of a failed shoulder prosthesis.

For a reverse shoulder application, a Glenosphere Baseplate with a Glenosphere is implanted into the glenoid side of the joint. The Glenoid Baseplate is attached to the natural bone with the use of a Central Screw and Peripheral Screws. A Humeral Tray with natural Bearing is attached to a Comprehensive® Humeral Stem to complete the a Hameral side of the joint. The use of a standard Comprehensive® humeral component namoral olde of the form of leaving a well-fixed humeral stem from a previous total or hemi-shoulder surgery in place while still being able to convert the shoulder to a reverse configuration. It also would facilitate the conversion of a reverse configured shoulder to a hemi-shoulder in the future if the need were to arise.

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Intended Use: Biomet Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy in pationer viously failed shoulder joint replacement with a grossly deficient rotator cuff. The pation 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 The oomprehono "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 Baseplate inuments are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated Intential 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.

Summary of Technologies: The Comprehensive® Reverse Shoulder has similar technologies as the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks of property of Biomet, Inc. except for the following: Anatomical Shoulder is a trademark of Zimmer GMBH Analomical Shouldor 10 a trademark of Zimmer Trabecular Metal Technology, Inc. Equinoxe is a trademark of Exactech, Inc.