SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM

K130126 · Biomet, Inc. · MBF · Aug 6, 2013 · Orthopedic

Device Facts

• Record ID: K130126
• Device Name: SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: MBF · Orthopedic
• Decision Date: Aug 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2

Intended Use

The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans. The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments. The Signature Glenoid Guide is intended for single use only.

Device Story

System uses preoperative CT imaging data to create 3D patient-specific models; software generates patient-specific glenoid guides based on identifiable anatomical landmarks. Guides are manufactured via additive manufacturing (plastic). Used intra-operatively by surgeons to facilitate accurate placement of metallic bone pins for glenoid component orientation. Compatible with Comprehensive Total and Reverse Shoulder Systems. Benefits include improved surgical planning and component positioning accuracy. Single-use device.

Clinical Evidence

No clinical data provided. Substantial equivalence determined via bench testing, including cadaver lab accuracy performance testing, guide verification of post-processing techniques, autoclave sterility deformation, and dimensional stability testing.

Technological Characteristics

Patient-specific glenoid guides manufactured from plastic using additive manufacturing. System utilizes preoperative CT imaging and software to generate 3D models. Single-use, non-sterile as manufactured (autoclave sterilization required).

Indications for Use

Indicated for use as a surgical instrument to assist in the intra-operative positioning of glenoid components during shoulder arthroplasty procedures. Used in conjunction with Comprehensive Total and Reverse Shoulder Systems requiring an initial center pin or hole. Intended for single use.

Regulatory Classification

Identification

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

Predicate Devices

• NaviPro Shoulder System (K050897)
• Signature Personalized Patient Care System- Acetabular Guide System (K111863)

Reference Devices

• Modular Hybrid Glenoid/Comprehensive Reverse Shoulder Instruments (510(k) Exempt)

Submission Summary (Full Text)

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## AUG 0 6 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 | |
| | Warsaw, IN 46581-0857 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment | 1825034 | |
| Registration Number | | |
| Name of contact | Tracy Bickel Johnson, RAC | |
| person | | |
| Date prepared | July 25, 2013 | |
| Name of device | | |
| Trade or proprietary<br>name | Signature™ Personalized Patient Care System - Glenoid Guide System | |
| Common or usual | Shoulder instruments | |
| name | | |
| Classification<br>name | prosthesis, shoulder, semi-constrained, metal/polymer | |
| Regulation | cemented (§ 888.3660) | |
| | prosthesis, shoulder, non-constrained, metal/polymer<br>● | |
| | cemented (§ 888.3650) | |
| | prosthesis, shoulder, semi-constrained, metal/polymer + | |
| | additive, cemented (§ 888.3660) | |
| | prosthesis, shoulder, semi-constrained, metal/polymer, | |
| | uncemented (§ 888.3670) | |
| Classification panel | Orthopedic | |
| Product Code(s) | KWS, KWT, PAO, and MBF | |
| Legally marketed device(s) to | (Reference Device) Modular Hybrid Access<br>● | |
| which equivalence is claimed | Glenoid/Comprehensive Reverse Shoulder Instruments (Biomet, | |
| | Inc.)- 510(k) Exempt | |
| | NaviPro Shoulder System (Kinamed, Inc.)- K050897<br>● | |
| | Signature Personalized Patient Care System- Acetabular Guide | |
| | System (Materialise, NV)- K111863 | |
| | New patient specific glenoid quides | |
| Reason for 510(k) submission<br>Device description | Patient specific guides are designed and manufactured in plastic using | |
| | additive manufacturing. The guides are developed using patient | |
| | imaging scans, software, and the clinician approved/finalized pre- | |
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| | landmarks of the shoulder that are identifiable<br>anatomical<br>on | |
| Intended use of the device<br>Indications for use | surgical plan. The guides facilitate the placement of metallic pins and<br>can be used in conjunction with existing anatomic and reverse Biomet<br>instrumentation and surgical techniques.<br>Intraoperative placement of metallic bone pins in arthroplasty<br>procedures.<br>The Signature Personalized Patient Care System - Glenoid<br>Guide System is intended to be used as a surgical instrument to<br>assist in the positioning of glenoid components intra-operatively using | |
| | | |
| | preoperative imaging scans. | |
| | The Signature Personalized Patient Care System - Glenoid<br>Guide System can be used in conjunction with the Comprehensive<br>Total and Reverse Shoulder Systems (including the Modular Hybrid<br>Glenoid, Bio-Modular Heads and Stems), and their respective<br>components, which require placement of an initial center pin or hole<br>to quide the associated system instruments.<br>The Signature Glenoid Guide is intended for single use only. | |
| | | |
| Summary of the Technologies<br>Signature™ Glenoid Guide System consists of various software systems to create patient specific glenoid<br>quides to facilitate the orientation of the central pin for glenoid preparation. The CT patient imaging data<br>is collected preoperatively and used to create three-dimensional "models" which are then transferred to a<br>glenoid template resulting in a guide that can place anatomic and reverse shoulder components. | | |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS | | |
| | | |
| Performance Test Summary-New Device | | |
| Accuracy performance testing (cadaver lab) and Guide verification of post processing techniques<br>and autoclave sterility deformation dimensional stability testing was performed to determine<br>substantial equivalence. | | |
| Planned trajectories analysis for Signature and Predicate | | |
| Packaging/Sterilization Testing | | |
| Pathologic Model Analysis | | |
| | Testing verified that the accuracy and performance of the system is adequate to perform as intended. | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | | |
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | |
| Clinical Performance Data/Information: N/A | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | |
| | | |

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The results of mechanical testing indicated 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 6, 2013

Biomet, Incorporated % Ms. Tracy Bickel Johnson Global Regulatory Project Manager 56 East Bell Drive Warsaw, Indiana 46581

Re: K130126

Trade/Device Name: Signature" Personalized Patient Care System - Glenoid Guide System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWT, KWS, PAO Dated: June 21, 2013 Received: June 24, 2013

Dear Ms. Johnson:

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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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Page 2 - Ms. Tracy Bickel Johnson

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDeyices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin I. Keith

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): K130126

Device Name: Signature™ Personalized Patient Care System - Glenoid Guide System

Indications For Use:

## INDICATIONS FOR USE

The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans.

The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments.

The Signature Glenoid Guide is intended for single use only.

Prescription Use ___ X (Part 21 CFR 801 Subpart D) AND/OR AND/OR AND/OR AND/OR CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CANALE CONT

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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