BIO-MODULAR REVERSE SHOLDER

K093803 · Biomet Manufacturing Corp · PHX · Oct 19, 2010 · Orthopedic

Device Facts

• Record ID: K093803
• Device Name: BIO-MODULAR REVERSE SHOLDER
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Oct 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bio-Modular® 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 Bio-Modular® 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.

Device Story

Reverse shoulder prosthesis; replaces traditional shoulder joint anatomy by placing ball on glenoid side and polyethylene bearing on humeral side. Components include Glenosphere Baseplate, Glenosphere, Central/Peripheral Screws, Humeral Tray, Humeral Bearing, and Humeral Stem. Used in orthopedic surgery for total shoulder replacement; allows conversion of existing well-fixed humeral stems to reverse configuration or future conversion to hemi-shoulder. Surgeon-operated; provides pain relief and restores function in patients with rotator cuff deficiency. Benefits include modularity for revision procedures and anatomical restoration.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing (fatigue testing) and engineering analysis (separation loads, change of face angle, assembly/disassembly, and range of motion).

Technological Characteristics

Semi-constrained, cemented/uncemented shoulder prosthesis. Materials include metal and polymer. Modular design allows integration with existing humeral stems. Features glenoid baseplate, glenosphere, humeral tray, and humeral bearing. Evaluated via fatigue testing and engineering analysis for mechanical integrity and range of motion.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy, or failed prior shoulder replacement with deficient rotator cuff. Requires functional deltoid muscle and suitable anatomy. Used 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® Reverse Shoulder (K080642)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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 P.O. Box 587 Warsaw, Indiana 46531

Re: K093803

Trade/Device Name: Bio-Modular® 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: October 14, 2010 Received: October 15, 2010

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of October 19, 2010.

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

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forth in the quality systems (OS) 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/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): KD93803

K093803 OCT 1 9 2010

Device Name: Bio-Modular® Reverse Shoulder

Indications For Use:

The Bio-Modular® 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 Bio-Modular® 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.

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)

Oputu for nxn
(Division Sign-On)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093803

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Image /page/3/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo is a stylized version of the word "BIOMET" in a rectangular box. Below the logo, the words "MANUFACTURING CORP." are printed in a simple font. To the right of the logo is the number K093803.

OCT 1 9 2010

## 510(k) Summary

Preparation Date: October 19, 2010

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: Bio-Modular ® Reverse Shoulder

Common Name: Shoulder Prosthesis

- Classification Name: Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis (21 CFR 888.3660) Shoulder joint metal/polymer, semi-constrained, uncemented prosthesis (21 CFR 888.3670)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Comprehensive® Reverse Shoulder (Biomet) - K080642

Device Description: The Bio-Modular ® 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 joint 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 qlenoid 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 a Humeral Bearing is attached to a Bio-Modular® Humeral Stem to complete the humeral side of the joint. The use of a standard Bio-Modular ® humeral component provides the surgeon with the option of leaving a well-fixed humeral stem from a previous total or hemishoulder 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.

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Man Fax: [phone]
www.biomel.com

**Shipping Address:**
56 East Bell Drive
Warsaw, IN 46582

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1, Pa

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K093803

510(k) Summary Bio-Modular® Reverse Shoulder Page 2

Intended Use: Biomet Bio-Modular® Reverse Shoulder products are 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 Bio-Modular® 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.

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

Non-Clinical Testing: Non-clinical laboratory testing (fatique testing) and engineering analysis (separation loads, change of face angle, assembly/disassembly and range of motion) were performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. Magnetic Resonance Imaging (MRI) studies have been conducted.

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

All trademarks of property of Biomet, Inc.

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