VANGUARD COMPLETE KNEE SYSTEM

K113550 · Biomet Manufacturing Corp · JWH · Feb 29, 2012 · Orthopedic

Device Facts

• Record ID: K113550
• Device Name: VANGUARD COMPLETE KNEE SYSTEM
• Applicant: Biomet Manufacturing Corp
• Product Code: JWH · Orthopedic
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (interlok") devices and all polyethylene patellar components are indicated for cemented application only.

Device Story

Vanguard Complete Knee System is a total knee replacement prosthesis for primary or revision arthroplasty. System components include femoral components (cast Co-Cr-Mo, ASTM F-75) with porous plasma spray or Interlok surface finish, tibial bearings (UHMWPE, ASTM F-648, including a-tocopherol variants), and patellar components (UHMWPE, ASTM F-648). Device is used by orthopedic surgeons in clinical/OR settings to replace damaged knee joint surfaces. Components provide mechanical articulation to restore joint function, reduce pain, and correct deformities. Fixation is achieved via cement or biological ingrowth (porous-coated components). System is designed to interface with existing Vanguard tibial trays.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical mechanical testing, including tibial-femoral and patello-femoral contact area analysis, mechanical stability, constraint testing, fatigue testing, and wear testing.

Technological Characteristics

Materials: Cast Co-Cr-Mo (ASTM F-75) for femoral components; UHMWPE (ASTM F-648) for bearings and patellar components. Surface finishes: Porous plasma spray or Interlok. Design: Semi-constrained, patellofemorotibial prosthesis. Fixation: Cemented or uncemented (porous-coated).

Indications for Use

Indicated for patients with painful, disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments; correction of varus, valgus, or post-traumatic deformity; and correction or revision of failed osteotomy, arthrodesis, or previous total joint replacement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Vanguard® CR Knee System (K023546)
• Vanguard® CR Knee System (K033489)
• Vanguard® PS+ Bearings (K041046)
• Vanguard® AS Tibial Bearings (K050222)
• Vanguard® PS Open Box Porous Femoral (K060303)
• Vanguard® Single Peg Patella (K061340)
• E1® Tibial Components (previously E-poly) (K080528)

Submission Summary (Full Text)

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FEB 2 9 2012

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# 510(k) Summary

| Preparation Date: | 28 November, 2011 |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0857<br>Establishment Registration No. 1825034 |
| Contact Person: | Gary Baker, MS RAC<br>Senior Regulatory Affairs Specialist<br>Biomet Manufacturing Corp.<br>56 East Bell Drive<br>Warsaw, Indiana 46580<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Proprietary Name: | Vanguard® Complete Knee System |
| Common Name: | Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous- coated<br>uncemented prosthesis (21CFR §888.3565) |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis (21CFR §888.3560) |
| Classification Name: | Knee joint patellofemorotibial polymer+Additive/metal/polymer+Additive<br>semi-constrained cemented prosthesis (21CFR §888.3560) |
| Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | K023546 Vanguard® CR Knee System<br>K033489 Vanguard® CR Knee System<br>K041046 Vanguard® PS+ Bearings<br>K050222 Vanguard® AS Tibial Bearings<br>K060303 Vanguard® PS Open Box Porous Femoral<br>K061340 Vanguard® Single Peg Patella<br>K080528 E1® Tibial Components (previously E-poly) |

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Device Description: The Vanguard® Complete Knee System is a total knee replacement system for either primary or revision knee arthroplasty. It consists of femoral components composed of cast Co-Cr-Mo per ASTM F-75 with either a porous plasma spray (PPS) or Interlok® surface finish, tibial bearings molded of polyethylene (UHMWPE) conforming to ASTM F-648 or machined of polyethylene (UHMWPE or UHMWPE with a-tocopherol) conforming to ASTM F-648, tibial trays (not part of this submission) and patellar components machined of polvethylene (UHMWPE) conforming to ASTM F-648.

Intended Use: Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (interlok") devices and all polyethylene patellar components are indicated for cemented application only.

Summary of Technologies: The Vanguard® Complete Knee System components have the same technological characteristics as the predicate components with the exception of the modifications described within this 510(k). Non-clinical testing was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components.

Non-Clinical Testing: Mechanical testing was previously performed to determine substantial equivalence. All testing met or exceeded the established acceptance criteria. The following test reports were provided in the predicate 510(k)s.

Tibial-femoral Contact Area, Patello-femoral Contact Area. Patellofemoral Mechanical Stability, Tibialfemoral Constraint, Tibialfemoral Mechanical Stability, Posterior Stabilized Fatigue, Posterior Stabilized Static Load, Range of Motion Analysis. 80/20 Femoral Fatigue, Vanguard® PS Open Box Tensile Stress, Constraint testing of AS and CR-L, Contact Area Analysis (AS bearing), Static Rotational Strength Test (PS+), Varus/Valgus Constraint (PS+), Tensile Strength E-poly, Wear Testing E-poly, and Contact Areas Analysis (patellar)

Clinical Testing: Clinical data is not necessary for a determination of substantial equivalence.

Conclusion: The Vanguard® Complete Knee System is substantially equivalent to previously cleared Biomet knee systems and do not raise any new issues of safety or efficacy.

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#### Public Health Service

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

Biomet Manufacturing Corp. % Mr. Gary Baker, MS RAC Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46580

FEB 2 9 2012

Re: K113550

Trade/Device Name: Vanguard Complete Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY . Dated: November 28, 2011 Received: December 1, 2011

Dear Mr. Baker:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Gary Baker

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erina Keith

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Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health

Enclosure

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## Indications for Use

KIJSEED 510(k) Number (if known):

Device Name: Vanguard® Complete Knee System

### Indications For Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved;

2. Correction of varus, valgus, or posttraumatic deformity;

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous total joint replacement procedure.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NQ (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)

K

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

KII 3 E CO 510(k) Number_