RINGLOC + HYBRID ACETABULAR SYSTEM

K093235 · Biomet, Inc. · KWA · Apr 30, 2010 · Orthopedic

Device Facts

• Record ID: K093235
• Device Name: RINGLOC + HYBRID ACETABULAR SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty.

Device Story

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is a series of acetabular shells used in hip arthroplasty to replace a damaged natural acetabulum. The device is implanted by a surgeon in a clinical setting. It features a titanium alloy shell with a porous plasma spray coating to facilitate bone integration. The system utilizes the Ringloc + locking mechanism, allowing compatibility with Biomet's M2a Ringloc Acetabular Liners or conventional Ringloc UHMWPE liners. By providing a stable, uncemented acetabular component, the device restores joint function and addresses deformities or fractures, ultimately aiming to reduce pain and improve mobility for patients requiring hip replacement or revision surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy shell (ASTM F-136) with porous plasma spray coating of titanium alloy powder (ASTM F-1580). Uncemented acetabular prosthesis. Features Ringloc + locking mechanism for modular liner compatibility.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, femoral neck, trochanteric) unmanageable by other techniques, and revision procedures. Intended for uncemented use only.

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

• M2a Ringloc® Acetabular Liners (K002379)
• Regenerex Ringloc + Modular Acetabular Shell (K070369)

Submission Summary (Full Text)

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BIOMET
MANUFACTURING CORP.

APR 3 0 2010

## 510(k) Summary Preparation Date: 8 April, 2010 Applicant/Sponsor: Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Contact Person: Gary Baker, MS RAC Regulatory Affairs Project Manager Biomet Manufacturing Corp. Tel: [phone] Ext. 1568 Fax: [phone] e-mail: [e-mail] Porous Plasma Spray (PPS) Ringloc®+ Acetabular System Proprietary Name: Acetabular System Common Name: Classification Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis. 21 CFR §888.3330 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. 21 CFR \$888.3358 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. 21 CFR 8888.3353 Product Code: KWA, LPH, LZO Legally Marketed Devices To Which Substantial Equivalence Is Claimed: M2a Ringloc® Acetabular Liners – K002379 Regenerex Ringloc + Modular Acetabular Shell - K070369

K093235

Device Description: The Porous Plasma Spray (PPS) Ringloc + Acetabular System is a series of acetabular shells that incorporate the Ringloc + locking mechanism design of the predicate Regenerex Ringloc 4 Modular Acetabular Shells. The Porous Plasma Spray (PPS) Ringloc + Acetabular System shells are compatible with Biomet's M2a Ringloc® Acetabular Liners or the conventional Ringloc® UHMWPE liners that are currently on the market.

Section III - Page 1 - 7 2

On Box 587 Narsaw IN 46581-0587 11 Free: 800-348 95 Office: 574 267 6639 Main Fax: [phone]

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

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## K093235

Intended Use: The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty.

## Indications For Use:

- 1. Non-inflammatory 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 by other techniques.
- 5. Revision procedures where other treatment or devices have failed.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended for uncemented use only.

Summary of Technologies: The subject Porous Plasma Spray (PPS) Ringloc®+ Acetabular System shells are made of titanium alloy conforming to ASTM F-136 with a porous plasma spray outer surface coating of titanium alloy powder conforming to ASTM F-1580.

Testing: Since the locking mechanism of the subject and predicate devices is identical, no testing was required to demonstrate substantial equivalence of the Porous Plasma Spray (PPS) Ringloc + Acetabular System to the predicate Regenerex Ringloc - + Modular Acetabular (1 - U - Ringlos -

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

## APR 3 0 2010

Biomet Manufacturing Corp. % Mr. Gary Baker, MS RAC Regulatory Affairs Project Manager 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K093235

Trade/Device Name: Porous Plasma Spray (PPS) Ringloc + Acetabular System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented · acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH, LZO Dated: April 08, 2010 Received: April 13, 2010

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. 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

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Page 2 - Mr. Gary Baker, MS RAC

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.

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,

Chabarebneher

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

Enclosure

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510(k) Number (if known): K093235

Device Name: Porous Plasma Spray (PPS) Ringloc + Acetabular System

Indications For Use:

- 1. Non-inflammatory 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 by other techniques.
- 5. Revision procedures where other treatment or devices have failed.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended for uncemented use only.

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)

Smuta der mxn

Division Sign-Off Division of Surgical. Orthobedic. and Restorative Devices

510(k) Number K093235

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