RINGLOC BI-POLAR ACETABULAR COMPONENT

• K Number: K051569
• Device Name: RINGLOC BI-POLAR ACETABULAR COMPONENT
• Manufacturer: BIOMET, INC.
• Date Cleared: 2005-09-29 ( 107 days)
• Product Code: JDI KWY LPH LZO MEH
• Regulation Number: 888.3350

Intended 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.

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.

Predicate Devices

K833175, K991990

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data-driven analysis.

Therapeutic

Yes
The device is intended for treating various joint diseases and fractures, which falls under therapeutic applications.

Diagnostic

No

Explanation: The device description and intended use indicate it is an orthopedic implant for joint replacement and fracture treatment, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components (outer shell, polyethylene insert, modular head component, metal ring) that are implanted in the body, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Description: The description clearly states that this is a Bi-Polar device consisting of a large outer shell, polyethylene insert, and modular head component designed to articulate with the natural acetabular bone and connect to a femoral hip stem. This is a surgical implant intended for use within the body.
• Intended Use/Indications for Use: The indications for use are all related to treating conditions affecting the hip joint and proximal femur through surgical intervention. These are not diagnostic uses.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

KWY, JDI, LPH, LZO, MEH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Testing: Mechanical testing of the assembly and disassembly forces was conducted.
Clinical Testing: None provided

Key Metrics

Not Found

Predicate Device(s)

K833175, K991990

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.

Summary

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SEP 2 9 2005

KOS/569

Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected to each other. The letters are black and the background is white. The word is centered in the image.

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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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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