COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS

K121183 · Biomet Corporation · PHX · Jul 26, 2012 · Orthopedic

Device Facts

• Record ID: K121183
• Device Name: COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
• Applicant: Biomet Corporation
• Product Code: PHX · Orthopedic
• Decision Date: Jul 26, 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 Baseplate 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

Comprehensive® Reverse Shoulder is a semi-constrained total shoulder prosthesis. Unlike traditional replacements, it uses a glenoid-side ball and humeral-side polyethylene bearing to increase deltoid muscle lever arm, providing stability and arm elevation for patients with non-functioning rotator cuffs. The E1® Antioxidant Infused Technology (vitamin E-infused, crosslinked UHMWPE) is incorporated into the humeral bearing to prevent oxidative degradation and cracking. The device is implanted by orthopedic surgeons in a clinical/surgical setting. The system includes various humeral stems (cemented or press-fit) and glenoid components (cementless with screw fixation or biological fixation). The surgeon selects components based on patient anatomy and fixation requirements to restore shoulder function and relieve pain.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing, including environmental stress cracking, small punch testing (ASTM F2183), and tensile testing (ASTM D638) following accelerated aging (ASTM F2003).

Technological Characteristics

Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis. Humeral bearings utilize E1® Antioxidant Infused Technology: isostatically compression molded GUR1020/GUR1050 UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E (alpha-tocopherol), and gamma sterilized (25-40 kGy) in argon. Glenoid components feature porous coating with optional Hydroxyapatite (HA) coating. Fixation methods include cemented, press-fit, or screw fixation.

Indications for Use

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

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 System (K080642)
• Comp. Reverse Shoulder - E1® Humeral Bearings (K113121)

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 46580

Re: K121183

Trade/Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, PAO, KWS Dated: April 13, 2012 Received: May 8, 2012

Dear Ms. Beres:

This letter corrects our substantially equivalent letter of July 26, 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 (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/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 ·

KIZII! 510(k) Number (if known):

Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims

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.

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 × (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)

Asif

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

510(k) Number k121183

Page 1 of 1

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JUL 26 2012

Image /page/3/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo is a stylized version of the word "BIOMET" with the letters connected and enclosed in a rectangular border. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The number K121183 is written in the upper right corner.

# 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 | 1825034 |
| Registration Number | |
| Name of contact person | Patricia Sandborn Beres<br>Senior Regulatory Specialist<br>Biomet Manufacturing Corp. |
| Date prepared | June 14, 2012 |
| NAME OF DEVICE | |
| Trade or proprietary<br>name | Comprehensive® Reverse Shoulder - E1® Polyethylene Claims |
| Common or usual name | Shoulder Prosthesis |
| Classification name | Shoulder joint, metal/polymer, semi-constrained, cemented<br>prosthesis |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3660 |
| Product Code(s) | KWS, PAO |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Comprehensive® Reverse Shoulder System - K080642<br>Comp. Reverse Shoulder - E1® Humeral Bearings - K113121 |
| Reason for 510(k)<br>submission | Claims language . |
| Device description | The Comprehensive® Reverse Shoulder is intended for total<br>shoulder replacement in a reverse shoulder configuration. Unlike<br>traditional total shoulder replacement, a reverse shoulder employs a<br>ball for articulation on the glenoid side of the joint and a<br>polyethylene bearing surface on the humeral side of the joint. This<br>device configuration increases the lever arm of the deltoid muscle<br>bundle to provide stability and the ability to raise the arm. This is<br>especially useful in cases where a patient has a non-functioning<br>rotator cuff which severely limits traditional joint replacement<br>options. |
| Intended use of the<br>device | Shoulder Replacement |
| Indications for use | The Comprehensive® Reverse Shoulder is indicated for use in<br>patients whose shoulder joint has a grossly deficient rotator cuff<br>with severe arthropathy and/or previously failed shoulder joint<br>replacement with a grossly deficient rotator cuff. The patient must<br>be anatomically and structurally suited to receive the implants<br>and a functional deltoid muscle is necessary.<br><br>The Comprehensive® Reverse Shoulder is indicated for primary,<br>fracture, or revision total shoulder replacement for the relief of<br>pain and significant disability due to gross rotator cuff deficiency.<br><br>Glenoid components with Hydroxyapatite (HA) coating applied over<br>the porous coating are indicated only for uncemented biological<br>fixation applications. The Glenoid Baseplate components are<br>intended for cementless application with the addition of screw<br>fixation.<br><br>Interlok® finish humeral stems are intended for cemented use and<br>the 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 HUMERAL BEARING<br>COMPARED TO THE PREDICATE | |
| The devices contained in this 510(k) are identical in material, dimensions, and attachment methods<br>to the devices contained in the predicate Comprehensive® Reverse Shoulder System 510(k)<br>submissions, K080642 and K113121 | |
| PERFORMANCE DATA | |
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Environmental Stress Cracking Testing | |
| Small punch Testing | |
| Tensile Testing per ASTM F648 | |
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence<br>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 indicated the material performed within the intended use, did not raise any new.<br>safety and efficacy issues and were found to be substantially equivalent to the predicate devices. | |

Matiing Address:
P.O. Box 5B7
Warbaw, IN 4E551-0587 Tod Fred: 800.346.9500 0:00:00:574.207.6639
Max Fax: [phone]
www.biomst.com Shipping Addross: 53 East Bell Drivo Via:saw, IN 46582

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K121183

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K12-1183

# CLAIMS FOR E1® ANTIOXIDANT INFUSED TECHNOLOGY*

#### Claim 1:

E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene. Environmental stress crack testing was conducted by cyclically loading GUR1020 and GUR1050 E1® test specimens in an air atmosphere maintained at 80℃ for 5 weeks. Testing was completed per the literature (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684). E1® specimens showed no evidence of environmental stress cracking and infrared spectroscopy showed no detectable oxidation in the loaded or unloaded samples (oxidation indices <0.1). E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE crosslinked with 100 kGy gamma irradiation under argon, doped with atocopherol, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

### Claim 2:

E1® Antioxidant Infused Technology protects polyethylene from oxidation and cracking during environmental stress crack testing. Environmental stress crack testing was conducted by cyclically loading test specimens in an air atmosphere maintained at 80°C for 5 weeks per the literature (Nabar, Sean, et al. Transactions of the 540 Annual Meeting of the ORS, Poster No. 1684). GUR1050 E1® specimens ran head to head with GUR1050 gamma sterilized (25-40kGy in argon) polyethylene and sequentially crosslinked and annealed polyethylene (GUR 1050 barstock, 33kGy gamma irradiated in air, annealed at 130C in air and repeated for a total dose of 99kGy and machined into final part geometry). GUR1020 E1® specimens ran head to head with GUR1050 direct compression molded polyethylene that was gamma sterilized (25-40kGy) in argon. The E1® material was the only material tested that showed no evidence of environmental stress cracking or fracture and no detectable oxidation indices <0.1) in the loaded and unloaded samples using infrared spectroscopy. Both gamma sterilized and sequentially crosslinked and annealed polyethylene showed evidence of increased oxidation and cracking or fracture during environmental stress crack testing. E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

### Claim 3: '

E1® Antioxidant Infused Technology maintains the mechanical strength of conventional UHMWPE under small punch testing. Small punch testing per ASTM F2183 was conducted for the E1® GUR1050 material and the E1® GUR1020 material. The E1® GUR1050 material was compared to GUR1050 gamma sterilized in argon isostatic compression molded (ICM) UHMWPE and the E1® GUR1020 material was compared to GUR1050 gamma sterilized (25-40kGy) in argon direct compression molded (DCM) UHMWPE. The ultimate load for the E1® GUR1050 material and the GUR1050 ICM

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K.1211.83

material are 105±5.5N and 75.4±5.3N respectively. The ultimate load for the E1® GUR1050 material and the DCM control material are 97.2±6.4N and 86.6±7.5N respectively. The E1® materials had ultimate loads greater than that of the ICM and DCM control. These differences were statistically significant (p<0.001 for all comparisons). E1® samples were machined from either GUR1020 or GUR1050 ICM UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

#### Claim 4 :

E1® Antioxidant Infused Technology maintains mechanical strength after accelerated aging. There was no significant decrease (P>0.05) in ultimate load , ultimate tensile strength, or yield strength after accelerated aging for either the E1® GUR1050 or the E1® GUR1020 material. Ultimate load was measured by small punch testing per ASTM F2183; ultimate tensile strength and yield strength were measured by tensile testing per ASTM D638; Accelerated aging was performed per ASTM F2003 (70°C and 5 atm of oxygen for 14 days). The ultimate load for the E1® GUR1020 material before and after accelerated aging was 97.2±6.4N and 100.0±5.0N respectively. The ultimate tensile strength for the E1® GUR1020 material before and after accelerated aging was 45.8±1.6 and 46.1±2.9 MPa respectively. The yield strength for the E1® GUR1020 material before and after accelerated aging was 22.6±0.2 and 22.8±0.3 MPa respectively. The ultimate load for the E1® GUR1050 material before and after accelerated aging was 105.0±5.5N and 115.0±3.2N respectively. The ultimate tensile strength for the E1® GUR1050 material before and after accelerated aging was 43±3 and 43±2 MPa respectively. The vield strength for the E1® GUR1050 material before and after accelerated aging was 24.2±0.2 and 24.4±0.2 MPa respectively. E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

* Note: E10 Antioxidant Infused Technology may be used interchangeably with any of the following: E19 Antioxidant Infused Bearings, E10 Antioxidant Infused Material, E10 material, E1® technology, E1® bearings, E1® liners, E1® acetabular liners, E1° Humeral Bearings and E1®