BIOMET MODULAR FEMORAL REVISION SYSTEM

K090757 · Biomet, Inc. · KWA · Sep 25, 2009 · Orthopedic

Device Facts

• Record ID: K090757
• Device Name: BIOMET MODULAR FEMORAL REVISION SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Indications for the Biomet® Modular Revision Femoral System Include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

Device Story

Biomet Modular Revision Femoral System is a press-fit, modular hip revision implant. System includes various proximal and distal body styles (broached, calcar-replacing, cone-style) and auxiliary fixation implants. Designed for uncemented application in femoral revision surgery. Surgeon selects modular components to reconstruct femoral defects. Single set of instrumentation provided. Device replaces damaged femoral bone structure to restore joint function and stability. Used in clinical/OR settings by orthopedic surgeons.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence. Bench testing only.

Technological Characteristics

Modular femoral revision system; press-fit, uncemented application. Components include proximal and distal bodies (broached, calcar-replacing, cone-style). Materials and design characteristics are consistent with predicate modular hip systems.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures of the proximal femur with head involvement, or those requiring revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Mallory-Head® Modular Calcar with and without HA—Biomet (K031693)
• Mallory-Head® Modular Calcar Stems with Interlocking Slots-Blomet (K042774)
• Restoration™ Modular System—Stryker (K013106)
• Restoration™ Modular System—Stryker (K022549)
• Modular Reach® Hip--Biomet (K994038)

Submission Summary (Full Text)

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K090757

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MANUFACTURING CORP.

# SEP 2 5 2009

### 510(k) Summary

Preparation Date:

March 20, 2009

Applicant/Sponsor:

Biomet Manufacturing Corp.

56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034

Contact Person:

Becky Earl Regulatory Specialist

Proprietary Name:

Common Name:

Classification Name:

Biomet® Modular Femoral Revision System

Femoral Hip Revision System

LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porqus Uncemented (21 CFR 888.3358)

KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (21 CFR 888.3330)

JDL- Prosthesis, Hip, Semi-Constralned (Metal Cemented Acetabular Component) (21 CFR 888.3320)

LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888,3353)

KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)

JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)

KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)

MAY-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)

MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)

Meiling Address: నిల్, విశ్ల క్యక్రిక Wargan 8 48 381-0587 To Frate (200 Manders) 0180 541 267 165 1488 Fax: [phone] ານປະຈິນ.Eວັນຕ່ອງໂດຍນາງ:

Shipping Address: 险会到 到10月份 Warst July 46582

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K090757

#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| K031693 | Mallory-Head® Modular Calcar with and without HA—Biomet |
|------------------|-------------------------------------------------------------------|
| K042774 | Mallory-Head® Modular Calcar Stems with Interlocking Slots-Blomet |
| K013106, K022549 | Restoration™ Modular System—Stryker |
| K994038 | Modular Reach® Hip--Biomet |

#### Device Description:

The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications

#### Intended Use:

Indications for the Biomet® Modular Revision Femoral System Include:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

The Blomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

#### Summary of Technologies:

The Biomet® Modular Revision Femoral System has the same technological haracteristics as the predicates listed above.

#### Non-Clinical Testing:

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

#### Clinical Testing:

None provided as a basis for substantial equivalence.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

SEP 2 5 2009

Re: K090757

Trade/Device Name: Biomet® Modular Femoral Revision System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY and MEH Dated: September 19, 2009 Received: September 21, 2009

Dear Ms. Earl:

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 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.

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### Page 2 - Ms. Becky Earl

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,

Hamil Clary

FOR

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

510(k) Number (if known): K090757

Device Name: Biomet® Modular Femoral Revision System

Indications For Use:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.

The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

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)

Jonita for MKN
This sign off

(Division Sign-Off)

Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K090757

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