RINGLOC CONSTRAINED LINERS II

K021728 · Biomet, Inc. · KWZ · Oct 25, 2002 · Orthopedic

Device Facts

• Record ID: K021728
• Device Name: RINGLOC CONSTRAINED LINERS II
• Applicant: Biomet, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ringloc® Constrained Liner is indicated for use as component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Device Story

Ringloc® Constrained Liner II is a polyethylene acetabular insert for total hip prostheses; features 10° beveled inner edge and locking ring to capture modular femoral head. Designed to prevent dislocation in high-risk patients. Modifications from previous generation include thicker locking ring, increased polyethylene around ring groove, and thicker polyethylene bumper. Used by orthopedic surgeons in clinical settings during hip replacement procedures. Device provides mechanical constraint to the hip joint, reducing risk of dislocation for patients with specific anatomical or neurological instability.

Clinical Evidence

No new clinical data provided. Device is a modification of a device previously studied under IDE #G990138. Substantial equivalence supported by mechanical testing and published medical literature.

Technological Characteristics

Metal/polymer constrained acetabular insert. Materials: Polyethylene liner with locking ring. Design features: 10° beveled inner edge, modified locking ring thickness, and increased polyethylene bumper. Class II device (21 CFR 888.3310).

Indications for Use

Indicated for primary and revision total hip arthroplasty patients at high risk of dislocation due to history of prior dislocation, bone loss, joint/soft tissue laxity, neuromuscular disease, or intraoperative instability, where other constrained options have been considered.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• Johnson & Johnson S-ROM® Poly-Dial Constrained Liner (P960054)
• Osteonics Constrained Acetabular Insert (P960047)

Reference Devices

• Ringloc® Constrained Liners (K950202)
• IDE #G990138

Submission Summary (Full Text)

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BIOMET

K021728

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## OCT 2 5 2002

#### SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Telephone: [phone] |
| Proprietary Name: | Ringloc® Constrained Liner II |
| Common Name: | Constrained Acetabular Insert |

Classification: Prosthesis, hip, constrained, metal/polymer (CFR 888.3310).

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROM® Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047.

Device Description: The Ringloc® Constrained Acetabular Liners II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.

The Ringloc® Constrained Liners II are the next generation in Biomet's constrained liner series. These constrained liners have been modified when compared to the Ringloc® Constrained Liners that were cleared in 510(k) K950202 and are now currently in IDE #G990138. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.

Indications for Use: The Ringloc® Constrained Liners II are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

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

> > .

SHIPPING ADDRESS 56 E. Bell Drive
Warsaw, IN 46582

.

()FFICE 574.267.66.39 FAX [phone]

E-MAIL [e-mail]

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Summary of Technologies: The Ringloc® Constrained Liners II-the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device.

Clinical Testing: The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138.

02/728

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 5 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K021728

Trade Name: RingLoc® Constrained Liner II Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: August 19, 2002 Received: August 20, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Dalene T. Binkley

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

b. Mark N. Mellaun

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

# 510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Ringloc® Constrained Liners II

INDICATIONS FOR USE:

The Ringloc® Constrained Liner is indicated for use as component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number -

Over-The-Counter-Use (Optional Format 1-2-96)

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