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
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K833175 , K991990
• Predicate For: K060707 , K101472 , K112019

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.

AI/ML Overview

The provided text describes a 510(k) submission for the RingLoc® Bi-Polar Acetabular Component. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study with a detailed protocol.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets them. Instead, it relies on demonstrating equivalence to predicate devices based on technological characteristics and mechanical testing.

Here's a breakdown of why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific, pre-defined performance thresholds for the new device.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of a performance study is described. The non-clinical testing mentioned is "Mechanical testing of the assembly and disassembly forces," but no details on sample size or data provenance for this testing are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment by experts is described.
4. Adjudication method for the test set: Not applicable. No clinical test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical implant, not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth is established for this 510(k) submission, as it does not involve a clinical performance study.
8. The sample size for the training set: Not applicable. No training set is relevant for this type of device submission.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is relevant.

In summary, the provided 510(k) summary explicitly states "Clinical Testing: None provided." This means the submission did not include a clinical study designed to establish acceptance criteria and prove performance against them as typically understood in a clinical trial or performance study context. Instead, the basis for approval is substantial equivalence to existing legally marketed devices, supported by non-clinical mechanical testing and verification of similar technological characteristics.

Summary

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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

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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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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.