RINGLOC BI-POLAR ACETABULAR COMPONENT

K051569 · Biomet, Inc. · JDI · Sep 29, 2005 · Orthopedic

Device Facts

• Record ID: K051569
• Device Name: RINGLOC BI-POLAR ACETABULAR COMPONENT
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

RingLoc® Bi-Polar Acetabular Component is a hip hemi-arthroplasty device; consists of a large outer shell with a polyethylene insert; captures a modular femoral head component of a hip stem. Outer shell surface articulates with natural acetabulum; outer diameters range 41mm to 70mm. Insert accepts 22mm or 28mm modular heads; secured by a pre-assembled thin metal ring snapping into an insert groove. Used by orthopedic surgeons in clinical settings to treat degenerative joint disease or proximal femur fractures. Device restores joint function by providing an articulating surface for the femoral head within the natural acetabulum.

Clinical Evidence

No clinical data provided. Bench testing of assembly and disassembly forces was conducted.

Technological Characteristics

Metal/polymer cemented or uncemented hip prosthesis. Components include a metal outer shell and polyethylene insert. Features a thin metal ring for insert retention. Sizing ranges from 41mm to 70mm outer diameter; accepts 22mm and 28mm modular heads. Mechanical assembly/disassembly design.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Biomet Bipolar Prosthesis (K833175)
• Biomet TriPolar System (K991990)

Submission Summary (Full Text)

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SEP 2 9 2005

KOS/569

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## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: RingLoc® Bi-Polar Acetabular Component

Common Name: Bi-Polar Acetabular Component

Classification Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet Bipolar Prosthesis (K833175), and Biomet TriPolar System (K991990)

Device Description: The Bi-Polar device consists of a large outer shell with a polyethylene insert that captures a modular head component of a femoral hip stem. The outer surface of the shell is highly outshed in order to articulate with the natural acetabular bone. Outer diameters of 41mm to 70mm allow politically of a fill the acetabular cavity. Inserts accept two size modular heads, 22mm and 28mm. The insert is held in place by a thin metal ring that is pre-assembled into the shell which snaps into a groove in the insert.

## Intended Use:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 1.
- 2. Rheumatoid arthritis
- Correction of functional deformity 3.
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head ধ: involvement, unmanageable using other techniques.

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the RingLoc® Bi-Polar Acetabular Components are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing of the assembly and disassembly forces was conducted.

Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

1

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

.

OFFICE 574.267.6639

FAX [phone]

62

E-MAIL [e-mail]

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SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K051569 Trade/Device Name: RingLoc® Bi-Polar Acetabular Component Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY, JDI, LPH, LZO, MEH Dated: September 21, 2005 Received: September 22, 2005

Dear Ms. Beres:

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 such 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); 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. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark H. Milliken

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): \$65 58 58 58 5

Device Name: RingLoc® Bi-Polar Acetabular Component

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.

Mark A. Milken

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Geich Devices Kosl569

510(k) Number_

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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