VANGUARD SSK 360 REVISION KNEE SYSTEM

K121149 · Biomet Manufacturing Corp · JWH · May 16, 2012 · Orthopedic

Device Facts

• Record ID: K121149
• Device Name: VANGUARD SSK 360 REVISION KNEE SYSTEM
• Applicant: Biomet Manufacturing Corp
• Product Code: JWH · Orthopedic
• Decision Date: May 16, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet® Splined Knee Stems V2 are intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed.

Device Story

Vanguard SSK 360 Revision Knee System modified to include updated splined knee stems. Stems provide additional stability to femoral or tibial knee components via cemented fixation. Device used by orthopedic surgeons in clinical settings during knee revision or total joint replacement procedures. Modifications involve design and size adjustments to splined stems. Engineering analysis confirms taper connection integrity remains consistent with predicate. Stems are MR Conditional. Device benefits patients by restoring joint function and stability in cases of severe arthritis or failed previous surgeries.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fit analysis performance testing and engineering justification for taper connection integrity.

Technological Characteristics

Splined knee stems; metal construction. Design modifications to stem geometry and size. MR Conditional. Cemented fixation for stems. Fundamental technology identical to predicate.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis; correction of varus, valgus, or posttraumatic deformity; and revision of failed osteotomy, arthrodesis, or previous total joint replacement. Regenerex femoral/tibial augments indicated for use with Vanguard Total Knee System and Biomet Tibial Trays. Porous coated components indicated for cemented/uncemented biological fixation; non-coated and all-polyethylene patellar components for cemented use only; Regenerex components for uncemented biologic fixation only.

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 360 Revision Knee System (K093293)

Submission Summary (Full Text)

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# MAY 1 6 2012

K121149

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### 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Preparation Date:

6 April. 2012

Applicant/Sponsor:

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Contact Person:

Gary Baker, MS RAC Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Tel: [phone] Ext .1568 Fax: [phone] e-mail: [e-mail]

Proprietary Name:

Vanguard® SSK 360 Revision Knee System - K093293

Knee joint patellofemorotibial, semi-constrained, cemented

polymer/metal/polymer (21 CFR § 888.3560)

Common Name:

Classification Name(s):

Product Code(s)

JWH

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Vanguard 360 Revision Knee System - K093293

Knee prosthesis

Device Description:

This submission describes modifications to compatible components of the Vanguard SSK 360 Revision Knee System. Specifically, the design and size offering was modified.

Intended Use:

The Biomet® Splined Knee Stems V2 are intended for cemented fixation to provide additional stability to femoral or tibial knee components where needed.

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Indications For Use:

Indications for Use:

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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.

The Regenerex™ femoral augments are indicated for use with the Vanguard" Total Knee System.

The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.

Summary of Technologies:
The Biomet® Splined Knee Stems V2 have the same technological characteristics as the predicate devices except for a slight modifications to the general design as described in this Special 510(k) notification. The changes do not affect the intended use or alter the fundamental scientific technology of the device. A risk analysis was conducted that evaluated the proposed modifications. The risk analysis concluded that the proposed modifications to the splined stems do not introduce any new risks.

Non-Clinical Testing:
Fit Analysis Performance Testing was conducted to determine the fit of the subject stems. All stems tested met the acceptance criteria of "acceptable stability". Secondary evaluation determined that the design modifications did not introduce any new risks of bone perforation or fracture.

An engineering justification evaluated the proposed modifications and demonstrated that the proposed design modifications would not affect the taper connection of the stems as compared to the predicate stems.

The modified stems are determined to be MR Conditional within the parameters of the previously tested Vanguard 360 Revision Knee System stems.

Clinical Testing:
Clinical Data was not required to demonstrate substantial equivalence to the predicate Vanguard® 360 Revision Knee System (K093293).

All trademarks are property of Biomet, Inc.

127

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

Biomet Manufacturing Corp. % Mr. Gary Baker, Senior Regulatory Specialist 56 East Bell Drive PO Box 587 Warsaw, IN 46581-0587

MAY 1 6 2012

Re: K121149

Trade/Device Name: Vanguard SSK 360 Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint patellofemorotibial, semi-constrained,

cemented polymer/metal/polymer

Regulatory Class: II Product Code: JWH Dated: April 12, 2012 Received: April 16, 2012

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. Iisting 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 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/CDRH0ffices/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

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

K121149

## 510(k) Number (if known):

Device Name: Vanguard® SSK 360 Revision Knee System

Indications for Use:

- 1. Painful and disabled knee joint resulting from osteoarthritis, theumatoid 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.

The Regenerex"" femoral augments are indicated for use with the Vanguard" Total Knee System.

The Regenerex " tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and allpolyethylene patellar components are indicated for cemented application only. Regenerex™ components are intended only for uncemented biologic fixation application.

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

Over-The-Counter Use NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. R. Sato

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

510(k) Number K121149

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